Medical device manufacturer
Johnson & Johnson Professionals, Inc.
Johnson & Johnson Professionals, Inc. holds 206 FDA 510(k) clearances across 84 product codes. Median elapsed review time is 59 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 206
- Product codes
- 84
- Median review
- 59 days
- Recall records
- 0
How does FDA spell Johnson & Johnson Professionals, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Johnson & Johnson Professionals, Inc. file in?
84 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 15 | 41 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 14 | 107 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 9 | 73 days | |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 9 | 108 days | |
| FPX | Strip, Adhesive, Closure, Skin | 7 | 19 days | |
| JXG | Shunt, Central Nervous System And Components | 7 | 194 days | |
| FRO | Dressing, Wound, Drug | 6 | 78 days | |
| KGX | Tape And Bandage, Adhesive | 6 | 16 days | |
| EXB | Collector, Ostomy | 5 | 16 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 22 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 149 days | |
| KLE | Agent, Tooth Bonding, Resin | 5 | 50 days | |
| EIH | Powder, Porcelain | 4 | 12 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 | 60 days | |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 3 | 18 days | |
| EBC | Sealant, Pit And Fissure, And Conditioner | 3 | 63 days | |
| EJJ | Alloy, Amalgam | 3 | 14 days | |
| GWM | Device, Monitoring, Intracranial Pressure | 3 | 88 days | |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 3 | 24 days | |
| ITG | Bandage, Cast | 3 | 10 days | |
| ITX | Transducer, Ultrasonic, Diagnostic | 3 | 206 days | |
| JOP | Transducer, Ultrasonic | 3 | 123 days | |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 3 | 67 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 79 days | |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 2 | 66 days |
Showing the 25 they file in most, of 84.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Johnson & Johnson Professionals, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Johnson & Johnson Professionals, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K992173 | SIPHONGUARD CSF CONTROL DEVICE | JXG | 284 | |
| K991413 | CODMAN ETHISORB DURA PATCH | GXQ | 325 | |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | GWM | 88 | |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | HCI | 163 | |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | KWY | 115 | |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | JDB | 59 | |
| K983014 | SUMMIT ACETABULAR SYSTEM | LPH | 60 | |
| K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | JXG | 137 | |
| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | JXG | 194 | |
| K980801 | J-FX BIPOLAR HEAD | KWY | 88 |
Source: openFDA device/510k · retrieved
Watch what Johnson & Johnson Professionals, Inc. files next
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