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
83521–83544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1999
SOLITAIRE 2
K993932 · EBF
Heraeus Kulzer, Inc.
Dental · 34d
Cleared Dec 22, 1999
MODULAR REACH HIP
K994038 · LPH
Biomet, Inc.
Orthopedic · 23d
Cleared Dec 22, 1999
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR...
K994039 · FRN
Abbott Laboratories
General Hospital · 23d
Cleared Dec 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS...
K994145 · JIS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Dec 21, 1999
KLS-MARTIN MMF SCREW
K980760 · DZL
KLS-Martin L.P.
Dental · 662d
Cleared Dec 21, 1999
IGM MININEPH ANTISERUM
K981784 · CFN
The Binding Site, Ltd.
Immunology · 580d
Cleared Dec 21, 1999
PATHFINDER II ANGIOGRAPHIC CATHETER
K990173 · DQO
Maxxim Medical
Cardiovascular · 336d
Cleared Dec 21, 1999
QUANTECH TOTAL B-HCG ASSAY
K990258 · NAL
Quantech , Ltd.
Chemistry · 328d
Cleared Dec 21, 1999
HEMOCHEK-A1C SAMPLE COLLECTION KIT
K990899 · LCP
Osborn Group, Inc.
Hematology · 278d
Cleared Dec 21, 1999
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
K991074 · MJH
Intracel Corp.
Microbiology · 265d
Cleared Dec 21, 1999
UNI-GOLD H. PYLORI
K991697 · LYR
Trinity Biotech, Plc
Microbiology · 217d
Cleared Dec 21, 1999
FIRST RESPONSE 1-STEP PREGNANCY
K992232 · LCX
Armkel, LLC
Chemistry · 172d
Cleared Dec 21, 1999
GRADILEIDEN V TEST
K992456 · GGW
Gradipore , Ltd.
Hematology · 151d
Cleared Dec 21, 1999
AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
K992502 · NAO
Axis
Chemistry · 148d
Cleared Dec 21, 1999
KEELER CRYO MASTER & PROBES
K992954 · HRN
Keeler Instruments, Inc.
Ophthalmic · 111d
Cleared Dec 21, 1999
BIO-RAD HOMOCYSTEINE BY HPLC
K993107 · LPS
Bio-Rad
Toxicology · 95d
Cleared Dec 21, 1999
PHILIPS INTURIS DICOM RECORDER
K993227 · LLZ
Philips Medical Systems North...
Radiology · 85d
Cleared Dec 21, 1999
RAPTOR TREATMENT PLANNING SYSTEM
K993359 · IYE
Nomos Corp.
Radiology · 76d
Cleared Dec 21, 1999
TONGUE STABILIZER DEVICE
K993381 · LRK
University of Otago
Dental · 75d
Cleared Dec 21, 1999
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
K993590 · LCP
Pointe Scientific, Inc.,
Chemistry · 60d
Cleared Dec 21, 1999
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
K993612 · MVM
The Binding Site, Ltd.
Immunology · 57d
Cleared Dec 21, 1999
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
K993645 · JAK
Ge Medical Systems, Inc.
Radiology · 54d
Cleared Dec 21, 1999
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
K993655 · GEI
Xomed, Inc.
General & Plastic Surgery · 53d
Cleared Dec 21, 1999
SNN FLUORO NAVIGATION SYSTEM
K993673 · HAW
I.S.G. Technologies, Inc.
Neurology · 50d