Company ยท US
Nobelpharma USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1999. Name variants (Inc, Corp, punctuation) are merged.
65510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 52 |
| NHA | Abutment, Implant, Dental, Endosseous | 4 |
| EIH | Powder, Porcelain | 1 |
| EJH | Alloy, Metal, Base | 1 |
| ELL | Teeth, Porcelain | 1 |
| ELM | Denture, Plastic, Teeth | 1 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | 1 |
| FZE | Prosthesis, Nose, Internal | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| LXB | Hearing Aid, Bone Conduction | 1 |
| MAH | Hearing Aid, Bone Conduction, Implanted | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 28, 1999 | K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE Nobelpharma USA, Inc. | MAH |
| Sep 6, 1996 | K962403 | NOBLEPHARMA WIDE ACCESSORIES Nobelpharma USA, Inc. | DZE |
| Aug 9, 1996 | K955713 | NOBELPHARMA BONE ANCHORED HEARING AID Nobelpharma USA, Inc. | LXB |
| Jul 22, 1996 | K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE Nobelpharma USA, Inc. | DZE |
| Jul 18, 1996 | K961736 | 17 ANGULATED ABUTMENT Nobelpharma USA, Inc. | NHA |
| Jul 10, 1996 | K961737 | CERA ONE ABUTMENT SYSTEM Nobelpharma USA, Inc. | DZE |
| Jul 10, 1996 | K961728 | MIRUSCONE ABUTMENT SYSTEM Nobelpharma USA, Inc. | NHA |
| May 14, 1996 | K960639 | ABUTMENT SELECTION KIT Nobelpharma USA, Inc. | DZE |
| Jan 30, 1996 | K955697 | ABUTMENT RETRIEVAL KIT Nobelpharma USA, Inc. | DZE |
| Jan 23, 1996 | K955372 | BALL ATTACHMENT SYSTEM Nobelpharma USA, Inc. | DZE |
| Oct 3, 1995 | K953435 | BRANEMARK RADIOGRAPHIC DEPTH GUAGE Nobelpharma USA, Inc. | DZE |
| Sep 27, 1995 | K953774 | BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY Nobelpharma USA, Inc. | DZE |
| Sep 21, 1995 | K953775 | BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) Nobelpharma USA, Inc. | DZE |
| Sep 18, 1995 | K952886 | BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM Nobelpharma USA, Inc. | DZE |
| Sep 18, 1995 | K952685 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS Nobelpharma USA, Inc. | DZE |
| Aug 11, 1995 | K952676 | BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM Nobelpharma USA, Inc. | DZE |
| Jun 26, 1995 | K933148 | SURGICAL DRAPE KIT Nobelpharma USA, Inc. | KKX |
| Jun 20, 1995 | K952448 | 3.3MM ACCESSORIES Nobelpharma USA, Inc. | DZE |
| Apr 13, 1995 | K945398 | BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE Nobelpharma USA, Inc. | DZE |
| Mar 8, 1995 | K944683 | BRANEMARK SYSTEM 3.3MM FIXTURE Nobelpharma USA, Inc. | DZE |
| Feb 28, 1995 | K944964 | BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM Nobelpharma USA, Inc. | DZE |
| Feb 27, 1995 | K944962 | BRANEMARK SYSTEM 17 ANGULATED ABUTMENT Nobelpharma USA, Inc. | DZE |
| Feb 17, 1995 | K944963 | BRANEMARK SYSTEM SMILINE II Nobelpharma USA, Inc. | DZE |
| Jan 13, 1995 | K945154 | BA-CPAS Nobelpharma USA, Inc. | FZE |
| Dec 2, 1994 | K944702 | PROCERA ALL-CERAMIC PORCELAIN Nobelpharma USA, Inc. | EIH |
| Aug 9, 1994 | K931785 | BRANEMARK SYSTEM DRILL CONTROLLER Nobelpharma USA, Inc. | DZE |
| Aug 8, 1994 | K934827 | BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM Nobelpharma USA, Inc. | DZE |
| Aug 8, 1994 | K934826 | BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104 Nobelpharma USA, Inc. | DZE |
| Aug 8, 1994 | K934825 | BRANEMARK SYSTEM Nobelpharma USA, Inc. | DZE |
| Aug 8, 1994 | K934495 | BRANEMARK SYSTEM(R) UCLA-TYPE ABUTMENT COMPLETE Nobelpharma AB | DZE |
| Aug 2, 1994 | K925766 | BRANEMARK SYSTEM TEMPORARY SOLUTIONS Nobelpharma USA, Inc. | DZE |
| May 2, 1994 | K925483 | BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276 Nobelpharma USA, Inc. | DZE |
| Feb 16, 1994 | K933149 | INSTRUMENT DETERGENT CONCENTRATE Nobelpharma USA, Inc. | FLG |
| Feb 10, 1994 | K925776 | BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND Nobelpharma USA, Inc. | DZE |
| Oct 20, 1993 | K933150 | NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE Nobelpharma USA, Inc. | DZE |
| Oct 20, 1993 | K925767 | BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP. Nobelpharma USA, Inc. | DZE |
| Oct 12, 1993 | K925762 | BRANEMARK SYSTEM SELF-TAPPING FIXTURE Nobelpharma USA, Inc. | DZE |
| Oct 12, 1993 | K925487 | NOBLEPHARMA BRANEMARK SYSTEM GOLD CYLINDERS Nobelpharma USA, Inc. | DZE |
| Oct 5, 1993 | K926501 | BRANEMARK SYSTEM(R) - 5.5MM FIXTURE Nobelpharma USA, Inc. | DZE |
| Oct 5, 1993 | K925765 | BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE Nobelpharma USA, Inc. | DZE |
| Oct 5, 1993 | K925764 | BRANEMARK SYSTEM 4.00 MM FIXTURE Nobelpharma USA, Inc. | DZE |
| Oct 5, 1993 | K925761 | BRANEMARK SYSTEM 5.0 X 14MM FIXTURE Nobelpharma USA, Inc. | DZE |
| Oct 5, 1993 | K925760 | BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE Nobelpharma USA, Inc. | DZE |
| Sep 16, 1993 | K925775 | BRANEMARK SYSTEM MACHINE INST. ACC. TO DRILLING EQ Nobelpharma USA, Inc. | DZE |
| Sep 16, 1993 | K925774 | BRANEMARK SYSTEM HAND INSTRUMENT Nobelpharma USA, Inc. | DZE |
| Sep 16, 1993 | K925772 | BRANEMARK SYSTEM GUIDE PINS Nobelpharma USA, Inc. | DZE |
| Sep 16, 1993 | K925770 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS Nobelpharma USA, Inc. | DZE |
| Sep 16, 1993 | K925768 | BRANEMARK SYSTEM SCREW TAP Nobelpharma USA, Inc. | DZE |
| Sep 13, 1993 | K920452 | THE BRANEMARK SYSTEM BALL ATTACHMENT ABUTMENT SYST Nobelpharma USA, Inc. | DZE |
| Jul 22, 1993 | K922805 | NOBELPHARMA TORQUE CONTROLLER Nobelpharma USA, Inc. | DZE |
Newest 50 of 65.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||