Company ยท US
Johnson & Johnson Professionals, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2000. Name variants (Inc, Corp, punctuation) are merged.
206510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 14 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 9 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 9 |
| FPX | Strip, Adhesive, Closure, Skin | 7 |
| JXG | Shunt, Central Nervous System And Components | 7 |
| FRO | Dressing, Wound, Drug | 6 |
| KGX | Tape And Bandage, Adhesive | 6 |
| EXB | Collector, Ostomy | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 |
| KLE | Agent, Tooth Bonding, Resin | 5 |
| EIH | Powder, Porcelain | 4 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 3 |
| EJJ | Alloy, Amalgam | 3 |
| GWM | Device, Monitoring, Intracranial Pressure | 3 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 3 |
| ITG | Bandage, Cast | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 7, 2000 | K992173 | SIPHONGUARD CSF CONTROL DEVICE Johnson & Johnson Professionals, Inc. | JXG |
| Mar 13, 2000 | K991413 | CODMAN ETHISORB DURA PATCH Johnson & Johnson Professionals, Inc. | GXQ |
| Jul 9, 1999 | K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT Johnson & Johnson Professionals, Inc. | GWM |
| Dec 18, 1998 | K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER Johnson & Johnson Professionals, Inc. | HCI |
| Dec 4, 1998 | K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) Johnson & Johnson Professionals, Inc. | KWY |
| Nov 6, 1998 | K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS Johnson & Johnson Professionals, Inc. | JDB |
| Oct 27, 1998 | K983014 | SUMMIT ACETABULAR SYSTEM Johnson & Johnson Professionals, Inc. | LPH |
| Jul 17, 1998 | K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM Johnson & Johnson Professionals, Inc. | JXG |
| Jul 1, 1998 | K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM Johnson & Johnson Professionals, Inc. | JXG |
| May 29, 1998 | K980801 | J-FX BIPOLAR HEAD Johnson & Johnson Professionals, Inc. | KWY |
| Apr 9, 1998 | K980081 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD Johnson & Johnson Professionals, Inc. | LZO |
| Apr 3, 1998 | K980286 | ULTIMA ACETABULAR ROOF REINFORCEMENT RING Johnson & Johnson Professionals, Inc. | JDI |
| Feb 6, 1998 | K974331 | UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM Johnson & Johnson Professionals, Inc. | LPH |
| Jan 9, 1998 | K974088 | CODMAN INTRACRANIAL BOLT Johnson & Johnson Professionals, Inc. | GWM |
| Dec 29, 1997 | K973774 | CODMAN HAKIM MICRO PRECISION VALVE Johnson & Johnson Professionals, Inc. | JXG |
| Nov 20, 1997 | K973307 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD Johnson & Johnson Professionals, Inc. | LZO |
| Sep 11, 1997 | K972435 | ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM Johnson & Johnson Professionals, Inc. | JDI |
| Jul 17, 1997 | K971189 | P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) Johnson & Johnson Professionals, Inc. | JWH |
| Jul 16, 1997 | K971652 | P.F.C. SIGMA INSET PATELLA Johnson & Johnson Professionals, Inc. | JWH |
| Jun 27, 1997 | K971682 | J-FX CERCLAGE SYSTEM Johnson & Johnson Professionals, Inc. | LRN |
| Jun 25, 1997 | K964923 | CODMAN LUMBAR DRAINAGE CATHETER KIT Johnson & Johnson Professionals, Inc. | JXG |
| Feb 19, 1997 | K964795 | CEMENTED CALCAR REPLACEMENT FEMORAL STEM Johnson & Johnson Professionals, Inc. | JDI |
| Jan 24, 1997 | K965156 | ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES Johnson & Johnson Professionals, Inc. | KWL |
| Dec 9, 1996 | K963885 | ULTIMA FX FEMORAL HIP STEMS Johnson & Johnson Professionals, Inc. | KWY |
| Nov 6, 1996 | K963117 | P.F.C. CRUCIATE RETAING KNEE SYSTEM Johnson & Johnson Professionals, Inc. | JWH |
| Oct 17, 1996 | K963206 | S-ROM HIP SYSTEM - LOCKING PLUG Johnson & Johnson Professionals, Inc. | JDI |
| Oct 10, 1996 | K954481 | P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM Johnson & Johnson Professionals, Inc. | HRY |
| Oct 8, 1996 | K963499 | MIRROR FINISH BIPOLAR FORCEPS Johnson & Johnson Professionals, Inc. | GEI |
| Sep 18, 1996 | K962429 | SAFETY VEST Johnson & Johnson Professionals, Inc. | FMQ |
| Aug 29, 1996 | K962248 | P.F.C. CERAMIC HIP HEAD Johnson & Johnson Professionals, Inc. | LZO |
| Aug 13, 1996 | K961939 | S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) Johnson & Johnson Professionals, Inc. | LPH |
| Jul 10, 1996 | K961685 | P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) Johnson & Johnson Professionals, Inc. | JWH |
| Mar 8, 1996 | K945518 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. | KWY |
| Jan 31, 1996 | K953202 | P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. | JDI |
| Jan 31, 1996 | K953200 | ULTIMA SIZE 0 CEMENTED FEMORAL STEM Johnson & Johnson Professionals, Inc. | JDI |
| Jan 31, 1996 | K952859 | ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. | JDI |
| Jan 30, 1996 | K955385 | JOHNSON & JOHNSON AUSTIN MOORE STEM Johnson & Johnson Professionals, Inc. | KWL |
| Jan 26, 1996 | K944544 | ABSORBABLE BONE SCREW Johnson & Johnson Professionals, Inc. | MAI |
| Jan 18, 1996 | K952830 | DARWIN KNEE SYSTEM (TC3) Johnson & Johnson Professionals, Inc. | JWH |
| Dec 6, 1995 | K954699 | BRAY RONGEUR Johnson & Johnson Professionals, Inc. | HAE |
| Nov 14, 1995 | K954851 | BIOPOLAR FORCEPS LINE Johnson & Johnson Professionals, Inc. | GEI |
| Nov 9, 1995 | K953730 | CODMAN ANTERIOR CERVICAL PLATE SYSTEM Johnson & Johnson Professionals, Inc. | KWQ |
| Oct 26, 1995 | K945585 | COMAN(R) CU-11 MODEL NUMBER 82-6634 Johnson & Johnson Professionals, Inc. | GWM |
| Oct 24, 1995 | K954021 | EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) Johnson & Johnson Professionals, Inc. | JXG |
| Jul 28, 1995 | K944222 | CODMAN-MEDOS VALVE SHUNT SYSTEM Johnson & Johnson Professionals, Inc. | JXG |
| Jul 5, 1995 | K952161 | BIPOLAR COAGULATION INSTRUMENT Johnson & Johnson Professionals, Inc. | GEI |
| Jun 7, 1995 | K950563 | ULTIMA AUGMENTED UHMWPE CUP Johnson & Johnson Professionals, Inc. | KWL |
| May 16, 1995 | K951934 | PFC CEMENT RESTRICTOR Johnson & Johnson Professionals, Inc. | LZN |
| May 15, 1995 | K950010 | DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED Johnson & Johnson Professionals, Inc. | JWH |
| Apr 10, 1995 | K945793 | P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR Johnson & Johnson Professionals, Inc. | KWY |
Newest 50 of 206.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||