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
84025–84048 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1999
STAT-SHELL DISPOSABLE SPO2 SENSOR
K992092 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 184d
Cleared Dec 22, 1999
SPO2 WRAP SENSOR
K992211 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 174d
Cleared Dec 22, 1999
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED...
K992390 · KGE
Telemed Systems, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 22, 1999
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X...
K992402 · KNS
Telemed Systems, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 22, 1999
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
K992587 · LSE
Stellar Bio Systems, Inc.
Microbiology · 142d
Cleared Dec 22, 1999
PARAGON LENS CARRIER
K993486 · LRX
Paragon Vision Sciences
Ophthalmic · 68d
Cleared Dec 22, 1999
PARAGON LENS VIAL
K993487 · LRX
Paragon Vision Sciences
Ophthalmic · 68d
Cleared Dec 22, 1999
SPACE-OR RETRACTOR
K993544 · FFO
Advanced Surgical Concepts (Asc)
Gastroenterology & Urology · 64d
Cleared Dec 22, 1999
ENIGMA HI-BASE DENTURE BASE MATERIAL
K993717 · EBI
Davis Schottlander & Davis, Ltd.
Dental · 49d
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