FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90913–90936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1997
ULTRACELL SUCTION SPONGE
K972634 · GDY
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 156d
Cleared Dec 17, 1997
PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
K972839 · FPA
Globe Ent., Inc.
General Hospital · 138d
Cleared Dec 17, 1997
PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S...
K972854 · FPA
Globe Ent., Inc.
General Hospital · 138d
Cleared Dec 17, 1997
PATHWAY ELECTROMYOGRAPH
K973537 · HCC
The Prometheus Group
Neurology · 90d
Cleared Dec 17, 1997
ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS
K973540 · IYE
Elekta Oncology Systems, Inc.
Radiology · 90d
Cleared Dec 17, 1997
GORE RESOLUT XT REGENERATIVE MATERIAL
K973594 · LYC
W.L. Gore & Associates, Inc.
Dental · 86d
Cleared Dec 17, 1997
VACUETTE MULTI-SAMPLE NEEDLE
K973620 · FMI
Greiner Meditech, Inc.
General Hospital · 85d
Cleared Dec 17, 1997
PRE-VIEW CHOLANGIOGRAPHY CLAMP
K973621 · GBZ
Nashville Surgical Instruments
General & Plastic Surgery · 85d
Cleared Dec 17, 1997
MINI FORCEPS WITH HF, 3.5MM
K973648 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 83d
Cleared Dec 17, 1997
VASOCOR PVR 100
K973659 · JOM
Vasocor, Inc.
Cardiovascular · 83d
Cleared Dec 17, 1997
DUODERM EXTRA THIN CGF DRESSING
K973716 · FRO
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 79d
Cleared Dec 17, 1997
COMBIDERM ACD
K973717 · FRO
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 79d
Cleared Dec 17, 1997
PILOT TUBE REPAIR KIT
K973755 · BSK
Instrumentation Industries, Inc.
Anesthesiology · 76d
Cleared Dec 17, 1997
DAPELLE HAIR REMOVER
K973773 · KCX
Wellquest Intl., Inc.
General & Plastic Surgery · 76d
Cleared Dec 17, 1997
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
K973793 · LMD
Olicon Imaging Systems, Inc.
Radiology · 72d
Cleared Dec 17, 1997
POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K973903 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 64d
Cleared Dec 17, 1997
POLYMER LATEX EXAMINATION GLOVES
K973904 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 64d
Cleared Dec 17, 1997
DBEST ONE-STEP HCG SERUM/URINE TEST
K973957 · JHI
Ameritek, Inc.
Chemistry · 62d
Cleared Dec 17, 1997
3M DENT SYSTEM II PLUS
K973961 · EMA
3M Company
Dental · 62d
Cleared Dec 17, 1997
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND...
K974013 · FPA
Sims Deltec, Inc.
General Hospital · 56d
Cleared Dec 17, 1997
PULPDENT DENTASTIC UNO
K974014 · EMA
Pulpdent Corp.
Dental · 56d
Cleared Dec 17, 1997
CENTURY ALLOY
K974035 · EJJ
Dentsply Intl.
Dental · 54d
Cleared Dec 17, 1997
ALLOY PRIMER
K974089 · KLE
Kuraray America, Inc.
Dental · 49d
Cleared Dec 17, 1997
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K974120 · LYZ
Shanghai Super Gloves Co., Ltd.
General Hospital · 47d