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
88585–88608 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1998
IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA...
K981226 · GQP
Dako Diagnostics , Ltd.
Microbiology · 188d
Cleared Sep 28, 1998
BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720
K981394 · DXH
Braemar Corp.
General Hospital · 164d
Cleared Sep 28, 1998
COAMATIC PLASMIN INHIBITOR
K981817 · GGP
Instrumentation Laboratory CO
Hematology · 129d
Cleared Sep 28, 1998
IS-VZU IGG TEST SYSTEM
K981867 · LFY
Diamedix Corp.
Microbiology · 123d
Cleared Sep 28, 1998
COBAS INTEGRA REAGENT CASSETTES
K982382 · CFN
Roche Diagnostic Systems, Inc.
Immunology · 82d
Cleared Sep 28, 1998
AST
K983131 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Sep 28, 1998
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN...
K983147 · DKE
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Sep 25, 1998
BLUNT SYRINGE CANNULA
K971924 · FMI
B.Braun Medical, Inc.
General Hospital · 490d
Cleared Sep 25, 1998
PRESS-MATE ADVANTAGE
K973637 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 366d
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