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
83449–83472 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2000
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K000363 · DDC
Zeus Scientific, Inc.
Immunology · 14d
Cleared Feb 18, 2000
MICROSTREP PLUS PANEL, LEVOFLOXACIN
K983943 · JWY
Dade Microscan, Inc.
Microbiology · 470d
Cleared Feb 18, 2000
ASP-100, MODEL 2100
K991345 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 305d
Cleared Feb 18, 2000
MRS-TITAN
K992359 · LZO
Rotec Medizintechnik GmbH
Orthopedic · 219d
Cleared Feb 18, 2000
MED-GUARD SURGEON'S GOWN
K992445 · FYA
Kappler USA
General Hospital · 211d
Cleared Feb 18, 2000
PERCUGUARD
K992539 · LZB
Digit-Pro
General Hospital · 203d
Cleared Feb 18, 2000
IBC VRV, MODEL 1350
K992657 · DWD
International Biophysics Corp.
Cardiovascular · 193d
Cleared Feb 18, 2000
SPOT ENDOSCOPIC MARKER
K993951 · NBG
Chek-Med Systems
Gastroenterology & Urology · 88d
Cleared Feb 18, 2000
CRYO-HIT
K993965 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 87d
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