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
82009–82032 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2000
ISLAND BIOSURGICAL BNS KIT #3
K001583 · KOD
Island Biosurgical, LLC
Gastroenterology & Urology · 52d
Cleared Jul 13, 2000
FOCUS
K001729 · EHD
Instrumentarium Corp.
Radiology · 36d
Cleared Jul 13, 2000
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001747 · LLZ
Barco NV Display Systems
Radiology · 35d
Cleared Jul 13, 2000
ELECSYS INSULIN CALSET
K001906 · JIS
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 13, 2000
HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING
K002003 · IYN
Atl Ultrasound, Inc.
Radiology · 13d
Cleared Jul 13, 2000
POCKET ULTRASONIC PACHYMETER
K993674 · IYO
Quantel Medical
Radiology · 255d
Cleared Jul 13, 2000
BRAINSCAN
K994413 · MUJ
Brainlab AG
Radiology · 197d
Cleared Jul 12, 2000
AMT THERAPEUTIC TABLE, MODEL 748AMT
K001401 · ITH
Amt Mfg., Inc.
Physical Medicine · 70d
Cleared Jul 12, 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421 · DKZ
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 12, 2000
AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
K001502 · BZC
Erich Jaeger GmbH
Anesthesiology · 58d
Cleared Jul 12, 2000
PASCO MIC AND MIC/ID PANELS
K001516 · JWY
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jul 12, 2000
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
K001524 · MQG
Thermoquest Corp.
Obstetrics & Gynecology · 57d
Cleared Jul 12, 2000
19 GA PLASTIC REINFORCED EPIDURAL CATHETER
K001587 · CAZ
Arrow Intl., Inc.
Anesthesiology · 50d
Cleared Jul 12, 2000
EBI ANTERIOR CERVICAL PLATE SYSTEM
K001794 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Jul 12, 2000
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804 · DXF
NuMED, Inc.
Cardiovascular · 27d
Cleared Jul 12, 2000
APEX FIXATION PINS
K001886 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 12, 2000
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
K001891 · GKP
Bio/Data Corp.
Hematology · 21d
Cleared Jul 12, 2000
AMPLATZER SIZING BALLOON
K993248 · MJN
Aga Medical Corp.
Cardiovascular · 288d
Cleared Jul 11, 2000
PUMA DENTAL CHAIR AND UNIT
K000837 · EIA
Castellini S.P.A.
Dental · 120d
Cleared Jul 11, 2000
KLINIDRAPE REINFORCED SURGICAL GOWNS
K000902 · FYA
Molnlycke Health Care, Inc.
General Hospital · 112d
Cleared Jul 11, 2000
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K001194 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 11, 2000
INSIDE VIEW
K001217 · GCM
Monadnock Optics, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 11, 2000
THE KALIX IMPLANT
K001231 · HWC
New Deal, S.A.
Orthopedic · 85d
Cleared Jul 11, 2000
BIOINSULATED SILICONE PUNCTUM PLUG
K001234 · LZU
Advanced Vision Science
Ophthalmic · 85d