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
88081–88104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1998
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05,...
K980817 · MQV
Interpore Intl.
Orthopedic · 206d
Cleared Sep 25, 1998
SILVERLON CONTACT WOUND DRESSING
K981299 · FRO
Argentum International, LLC
General & Plastic Surgery · 169d
Cleared Sep 25, 1998
MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES
K981940 · GCJ
Dexide, Inc.
General & Plastic Surgery · 115d
Cleared Sep 25, 1998
HYDROCISION ARTHROJET SYSTEM
K982266 · HRX
Hydrocision, Inc.
Orthopedic · 88d
Cleared Sep 25, 1998
VITAL SIGNS MONITOR
K982279 · MHX
Bci Intl., Inc.
Cardiovascular · 87d
Cleared Sep 25, 1998
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A
K982300 · KPS
Toshiba America Medical Systems, In.C
Radiology · 86d
Cleared Sep 25, 1998
DEVILBISS SUCTION UNIT
K982304 · JCX
Sunrise Medical Hhg, Inc.
General & Plastic Surgery · 86d
Cleared Sep 25, 1998
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K982330 · FTM
Depuy, Inc.
General & Plastic Surgery · 85d
Cleared Sep 25, 1998
A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR
K982481 · DXN
A&D Engineering, Inc.
Cardiovascular · 71d
Cleared Sep 25, 1998
THE BONE TIE
K982719 · HTY
Surgicraft , Ltd.
Orthopedic · 52d
Cleared Sep 25, 1998
HUMAPEN AND HUMAPEN ERGO
K982842 · FMF
Eli Lilly and Co.
General Hospital · 44d
Cleared Sep 25, 1998
POC ENT ENDOSCOPE - SINUSCOPE
K983123 · EOB
Precision Optics Corp.
Ear, Nose, Throat · 86d
Cleared Sep 25, 1998
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS
K983152 · MNH
Osteonics Corp.
Orthopedic · 16d
Cleared Sep 24, 1998
GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
K974572 · MDK
Chugai Pharmaceuticals Co., Ltd.
Microbiology · 293d
Cleared Sep 24, 1998
AIR TECHNIQUES' AIRDENT II
K981564 · KOJ
Air Techniques, Inc.
Dental · 146d
Cleared Sep 24, 1998
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205,...
K981985 · DHX
Beckman Coulter, Inc.
Immunology · 111d
Cleared Sep 24, 1998
CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH...
K982172 · GKZ
Coulter Corp.
Hematology · 97d
Cleared Sep 24, 1998
LASETTE LASER SKIN PERFORATOR
K982230 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 177d
Cleared Sep 24, 1998
FREE T4 MICROWELL EIA, MODEL #7019
K982954 · CEC
Biomerica, Inc.
Chemistry · 31d
Cleared Sep 24, 1998
ELECSYS MYOGLOBIN STAT ASSAY
K983176 · DDR
Boehringer Mannheim Corp.
Immunology · 14d
Cleared Sep 23, 1998
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
K974899 · FIP
Gambro Healthcare
Gastroenterology & Urology · 267d
Cleared Sep 23, 1998
ULTRA-COVER PU-TRANSDUCER COVER
K981069 · ITX
International Medical Products B.V.
Radiology · 183d
Cleared Sep 23, 1998
MAYFIELD ACCISS OPTICAL SYSTEM
K982244 · HAW
Ohio Medical Instrument Co., Inc.
Neurology · 90d
Cleared Sep 23, 1998
STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
K982400 · EMA
Steri-Oss, Inc.
Dental · 75d