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
89569–89592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1998
OSSEOTITE DENTAL IMPLANT SYSTEM
K980549 · DZE
Implant Innovations, Inc.
Dental · 90d
Cleared Apr 28, 1998
NTECH CYSTOSCOPES
K980592 · FAJ
N-Tech Endoscopy, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 28, 1998
HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED
K980848 · LYY
P.T. Irama Dinamika Latex
General Hospital · 55d
Cleared Apr 27, 1998
AUTOTRANSFUSION APPARTUS (AUTOLOG)
K972894 · CAC
Medtronic Blood Management
Anesthesiology · 265d
Cleared Apr 27, 1998
CSS-CARDIOPLEGIA SAFETY SYSTEM
K973237 · DWB
Medtronic Bio-Medicus, Inc.
Cardiovascular · 242d
Cleared Apr 27, 1998
PELVX RING, PELVX RING WITH SUPPORT
K974115 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 178d
Cleared Apr 27, 1998
PELVX INCONTINENCE RING
K974116 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 178d
Cleared Apr 27, 1998
PELVX DONUT, PELVX CUBE
K974117 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 178d
Cleared Apr 27, 1998
PALFIQUE ESTELITE
K980054 · EBF
Tokuyama America, Inc.
Dental · 111d
Cleared Apr 27, 1998
TOKUSO MAC BOND II
K980058 · EBF
Tokuyama America, Inc.
Dental · 111d
Cleared Apr 27, 1998
INNOVASIVE 10MM LINX HT LIGAMENT FASTENER
K980334 · MBI
Innovasive Devices, Inc.
Orthopedic · 89d
Cleared Apr 27, 1998
MANAN VS ACCESS NEEDLE/SET
K980372 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 87d
Cleared Apr 27, 1998
CLASS III REVERSE PULL FACEMASK
K980436 · DZB
Ortho Kinetics Corp.
Dental · 82d
Cleared Apr 27, 1998
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET...
K980583 · FPA
Sims Deltec, Inc.
General Hospital · 69d
Cleared Apr 27, 1998
BIOGOLD PLUS DENTAL ALLOY
K980660 · EJT
European Dental Imports, Inc.
Dental · 66d
Cleared Apr 27, 1998
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
K980772 · LBR
Diagnostic Chemicals , Ltd.
Chemistry · 66d
Cleared Apr 27, 1998
SYNTHES SCHUHLI IMPLANT SYSTEM
K980944 · HTN
Synthes (Usa)
Orthopedic · 46d
Cleared Apr 27, 1998
STRATUS CS CARDIAC TROPONIN I TESTPAK
K981098 · MMI
Dade Behring, Inc.
Chemistry · 32d
Cleared Apr 27, 1998
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · DDR
Dade Behring, Inc.
Immunology · 32d
Cleared Apr 27, 1998
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
K981178 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 26d
Cleared Apr 27, 1998
N-ASSAY L T-BIL
K981289 · CIG
Crestat Diagnostics, Inc.
Chemistry · 19d
Cleared Apr 25, 1998
AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER
K972911 · GAT
United States Surgical, A Division of...
General & Plastic Surgery · 261d
Cleared Apr 24, 1998
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR...
K972793 · DQX
Radi Medical Systems AB
Cardiovascular · 270d
Cleared Apr 24, 1998
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
K973556 · IYN
Imex Medical Systems, Inc.
Radiology · 217d