Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
141529–141552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1987
SHEER ENERGY, ACTIVE & SILKY SUPPORT PANTY HOSE
K863699 · DWL
Hanes Group
General Hospital · 134d
Cleared Feb 04, 1987
CHEMO-CATH INTRAPERITONEAL CATHETER
K863819 · FJS
Hdc Corp.
Gastroenterology & Urology · 127d
Cleared Feb 04, 1987
AMBULATORY INFUSION PUMP, MODEL AS30C
K863864 · FRN
Travenol Laboratories, S.A.
General Hospital · 124d
Cleared Feb 04, 1987
CLYDE (TM) FILTRATION SYSTEM
K864113 · FPB
Arbor Technologies, Inc.
General Hospital · 106d
Cleared Feb 04, 1987
STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
K864445 · CHL
Nova Biomedical Corp.
Chemistry · 84d
Cleared Feb 04, 1987
PODOSCOPE
K864499 · IKE
Broadwest Corp.
Physical Medicine · 82d
Cleared Feb 04, 1987
PSORALITE 12800 SERIES
K864510 · FTC
Psoralite Corp.
General & Plastic Surgery · 82d
Cleared Feb 04, 1987
PSORALITE 18400 SERIES
K864511 · FTC
Psoralite Corp.
General & Plastic Surgery · 82d
Cleared Feb 04, 1987
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
K864522 · LBS
Beckman Instruments, Inc.
Chemistry · 79d
Cleared Feb 04, 1987
ADX(TM) ANALYZER
K864566 · JJQ
Abbott Laboratories
Chemistry · 77d
Cleared Feb 04, 1987
PODODIGITAL
K864569 · IKE
Broadwest Corp.
Physical Medicine · 76d
Cleared Feb 04, 1987
HCG SOLID PHASE COMPONENT SYSTEM
K864591 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 75d
Cleared Feb 04, 1987
IMMUNO-SURE
K864611
Coulter Electronics, Inc.
Hematology · 72d
Cleared Feb 04, 1987
WHITESIDE ORTHOLOC II METAL BACKED PATELLA
K864627 · JWH
Dow Corning Wright
Orthopedic · 71d
Cleared Feb 04, 1987
BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH
K864659 · JLW
Bio Mega Diagnostic, Inc.
Chemistry · 68d
Cleared Feb 04, 1987
MODEL M402 EMG MONITOR
K864660 · IKN
Bio-Logic Devices
Neurology · 68d
Cleared Feb 04, 1987
UNIFAST CALCIUM TEST
K864661 · CIC
Sclavo, Inc.
Chemistry · 68d
Cleared Feb 04, 1987
CRYOTHERM
K864721 · ILJ
Grimm Scientific Industries, Inc.
Physical Medicine · 63d
Cleared Feb 04, 1987
CHUCK HANDLE
K864771 · GEI
New England Surgical Instrument Corp.
General & Plastic Surgery · 61d
Cleared Feb 04, 1987
BETAFLO 2000 PIGGYBACK SYSTEM
K864789 · LDR
Betaflo, Inc.
General Hospital · 58d
Cleared Feb 04, 1987
POIRIER POWERED WHEELCHAIR
K864791 · ITI
Roseburg SA
Physical Medicine · 58d
Cleared Feb 04, 1987
TSH MAB IRMA
K864839 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 57d
Cleared Feb 04, 1987
OMNI THERM TEMPERATURE MONITOR
K864853 · KPD
Omni Therm, Inc.
General Hospital · 55d
Cleared Feb 04, 1987
FERRIS DYNADERM PLUS
K865089 · FRO
Ferris Mfg. Corp.
General & Plastic Surgery · 36d