FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88609–88632 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 23, 1998
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING...
K982427 · OWB
Trex Medical Corp.
Radiology · 72d
Cleared Sep 23, 1998
EWC: ECG CABLE AND LEADWIRE SYSTEMS
K982817 · DSA
Ewc
Cardiovascular · 43d
Cleared Sep 23, 1998
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
K982960 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 23, 1998
XENON LIGHT SOURCE, MODELS LS6180, LS6035
K982962 · GCT
Contec Medical Vision, Ltd.
Gastroenterology & Urology · 30d
Cleared Sep 23, 1998
NBIL
K983134 · MQM
Abbott Laboratories
Chemistry · 15d
Cleared Sep 22, 1998
JM-102 JAUNDICE METER
K972309 · MQM
Air-Shields, Inc.
Chemistry · 459d
Cleared Sep 22, 1998
BIONECT HYDROGEL GAUZE PADS
K973721 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 357d
Cleared Sep 22, 1998
BIONECT HYDROGEL FOAM
K973722 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 357d
Cleared Sep 22, 1998
BIONECT HYDROGEL SPRAY
K973724 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 357d
Cleared Sep 22, 1998
BIONECT CLEAR HYDROGEL
K973725 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 357d
Cleared Sep 22, 1998
IMMUNODOT MONO-G TEST
K974226 · LSE
Genbio
Microbiology · 314d
Cleared Sep 22, 1998
IMMUNODOT MONO-M TEST
K974244 · LSE
Genbio
Microbiology · 314d
Cleared Sep 22, 1998
OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
K974685 · JDI
Osteonics Corp.
Orthopedic · 280d
Cleared Sep 22, 1998
KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II
K980398 · GEX
Optomedic Medical Technologies , Ltd.
General & Plastic Surgery · 232d
Cleared Sep 22, 1998
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
K980798 · LYR
Princeton BioMeditech Corp.
Microbiology · 204d