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
82945–82968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2000
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K993966 · DSP
Arrow Intl., Inc.
Cardiovascular · 87d
Cleared Feb 18, 2000
IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED...
K994076 · JWH
Implex Corp.
Orthopedic · 78d
Cleared Feb 18, 2000
PACIFIC HEMOSTASIS THROMBOPLASTIN D
K994100 · GJS
Pacific Hemostasis
Hematology · 77d
Cleared Feb 18, 2000
BONE GRAFT WASHER, MODEL 9090114 - 9090118
K994122 · KWQ
Danek Medical, Inc.
Orthopedic · 73d
Cleared Feb 18, 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL...
K994143 · JDW
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Feb 18, 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · FYA
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Feb 18, 2000
FRIOS MICROSAW
K994298 · KMW
Friadent GmbH
Dental · 59d
Cleared Feb 18, 2000
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP...
K994361 · MQK
Genesis Industries, Inc.
Obstetrics & Gynecology · 53d
Cleared Feb 18, 2000
EU-TTG IGA ELISA
K994379 · MVM
Scimedx Corp.
Immunology · 53d
Cleared Feb 18, 2000
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
K994424 · LRM
Diamedix Corp.
Immunology · 50d
Cleared Feb 17, 2000
HARDYDISK CEFAMANDOLE, 30MCG
K000022 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Feb 17, 2000
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
K000119 · KRH
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared Feb 17, 2000
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.)...
K991737 · DTZ
Dideco S.P.A.
Cardiovascular · 272d
Cleared Feb 17, 2000
PERMACOL
K992556 · FTL
Tissue Science Laboratories, Plc
General & Plastic Surgery · 202d
Cleared Feb 17, 2000
HARDYDISK OXACILLIN, 1MCG
K994134 · JTN
Hardy Diagnostics
Microbiology · 72d
Cleared Feb 16, 2000
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
K000159 · IXK
Agfa Corp.
Radiology · 28d
Cleared Feb 16, 2000
SYNERGY VLS CAP NUT MODELS 2206, 6102
K000236 · MNI
Interpore Cross Intl.
Orthopedic · 20d
Cleared Feb 16, 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES...
K000242 · MEH
Exactech, Inc.
Orthopedic · 20d
Cleared Feb 16, 2000
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT...
K000295 · KGO
Ansell Perry
General Hospital · 16d
Cleared Feb 16, 2000
IMPACT MODULAR TOTAL HIP SYSTEM
K000334 · LPH
Biomet, Inc.
Orthopedic · 13d
Cleared Feb 16, 2000
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA...
K000379 · DTM
Medtronic Vascular
Cardiovascular · 9d
Cleared Feb 16, 2000
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
K981936 · DQX
Advanced Biomedical Devices, Inc.
Cardiovascular · 624d
Cleared Feb 16, 2000
TMC-EASY-302
K984565 · INI
Tmc Magnetics & Machinery Corp.
Physical Medicine · 420d
Cleared Feb 16, 2000
SOMAVISION
K992751 · KPQ
Varian Assoc., Inc.
Radiology · 184d