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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
152545–152568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1984
ANKLE MOBILIZER
K842882 · BXB
Joint Mobilizer Systems, Inc.
Physical Medicine · 16d
Cleared Aug 08, 1984
AMPCO PROCEDURE TRAYS / PACKS
K843114
Associated Medical Products Co.
General Hospital
Cleared Aug 07, 1984
RENEAU UNIT
K840841 · CBF
Reneau, Inc.
Anesthesiology · 165d
Cleared Aug 07, 1984
WOODLYN CLASSIC SLIT LAMP HSSL-CL
K841761 · HLI
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN CLASSIC JAVAL OPHTHALMOMETER
K841764 · HLI
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN STANDARD SLIT LAMP HSSL-ST
K841765 · HLQ
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN CLASSIC KERATOMETER
K841767 · HLI
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
AMERICAN MEDICAL OPTICS PHOTOKERATO
K842128 · HJA
American Medical Optics
Ophthalmic · 70d
Cleared Aug 07, 1984
SERUM IRON & SERUM IRON BINDING CAPACI
K842155 · CFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Aug 07, 1984
SERUM IRON & SERUM IRON BINDING CAPACITY
K842156 · CFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Aug 07, 1984
IVAC 280 VOLUMETRIC INFUSION CONTROLLER
K842419 · LDR
Y
General Hospital · 48d
Cleared Aug 07, 1984
TDX REA IRON DIAGNOSTIC KIT
K842505 · CFM
Abbott Laboratories
Chemistry · 42d
Cleared Aug 07, 1984
DHEA-S DIRECT RIA KIT
K842555 · JKC
Biotecx Laboratories, Inc.
Chemistry · 36d
Cleared Aug 07, 1984
LUDLUM 88 DOSE CALIBRATOR
K842570 · KPT
Ludlum Measurements, Inc.
Radiology · 35d
Cleared Aug 07, 1984
COMMODE CHAIR 98200
K842651 · ILS
Guardian Products Co., Inc.
Physical Medicine · 28d
Cleared Aug 07, 1984
ROOTMAN ORBITAL SURGERY INSTRUMENT SET
K842697 · HNR
Downs Surgical , Ltd.
Ophthalmic · 27d
Cleared Aug 07, 1984
ORNITHINE INDOLE MOTILITY
K842851 · JSH
Anarobe Systems
Microbiology · 18d
Cleared Aug 07, 1984
DECARBOXYLASE TEST REAGENT
K842869 · JSF
Irvine Diagnostic Services
Microbiology · 15d
Cleared Aug 07, 1984
HIPPURATE TEST REAGENT
K842871 · JSF
Irvine Diagnostic Services
Microbiology · 15d
Cleared Aug 07, 1984
T- EXTENSION SET T-04-C
K842985 · FPA
Tico Medical Instruments, Inc.
General Hospital · 8d
Cleared Aug 07, 1984
VMT GENTLE-HALER
K842988 · CCQ
Vortran Medical Technology 1, Inc.
Anesthesiology · 8d
Cleared Aug 06, 1984
NEOS LP
K841633 · DXY
Biotronik Sales, Inc.
Cardiovascular · 109d
Cleared Aug 06, 1984
DESERET DISPOSABLE PRESSURE TRANSDUCER
K841968 · DRS
Parke-Davis Co.
Cardiovascular · 83d
Cleared Aug 06, 1984
INFUSAID INFUSE-A-PORT
K842355 · LJT
Infusaid Corp.
General Hospital · 46d