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
168169–168192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792454 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC VENTILATOR/RESUSCITATOR #2
K792455 · CBK
Pneupac , Ltd.
Anesthesiology · 64d
Cleared Feb 05, 1980
PNEUPAC VENTILATOR/RESUSCITATOR #3
K792456 · CBK
Pneupac , Ltd.
Anesthesiology · 64d
Cleared Feb 05, 1980
COMPRESSOR
K792457 · BTI
Pneupac , Ltd.
Anesthesiology · 64d
Cleared Feb 05, 1980
PNEUPAC TEST SET, PT.#500-A250
K792458 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC VENTILATOR/RESUSCITATOR
K792459 · CBK
Pneupac , Ltd.
Anesthesiology · 64d
Cleared Feb 05, 1980
ECA GEL
K792488 · GYB
Vanaray Laboratories, Inc.
Neurology · 64d
Cleared Feb 05, 1980
UCA CREAM
K792489 · IYO
Vanaray Laboratories, Inc.
Radiology · 64d
Cleared Feb 05, 1980
ECA CREAM
K792491 · GYB
Vanaray Laboratories, Inc.
Neurology · 64d
Cleared Feb 05, 1980
UCA GEL
K792492 · IYO
Vanaray Laboratories, Inc.
Radiology · 64d
Cleared Feb 05, 1980
PULSE GENERATOR, MODEL NO. LIT 222
K792526 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Feb 05, 1980
SORIN PULSE GENERATOR MODEL # LIT 214 H
K792565 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Feb 05, 1980
RMC KNEE METAL SHOE TIBIAL COMPONENTS
K792619 · HRY
Richard'S Medical Equip., Inc.
Orthopedic · 48d
Cleared Feb 05, 1980
PERMADYNE POLYETHER RUBBER IMPRESSION
K800031 · ELW
Espe Dental Products
Dental · 29d
Cleared Feb 05, 1980
PLATELET RETENTION (ADHESION) COLUMNS
K800037 · JBZ
Hemometrix
Hematology · 29d
Cleared Feb 05, 1980
KODAK EKTACHEM ELECTROLYTE ANALYZER
K800054 · CEM
Eastman Kodak Company
Chemistry · 27d
Cleared Feb 05, 1980
ASI REAGENT
K800065 · CIT
Gilford Diagnostics
Chemistry · 25d
Cleared Feb 05, 1980
ELECTRICAL MUSCLE STIMULATOR (EMS)
K800068 · IPF
Staodynamics, Inc.
Physical Medicine · 25d
Cleared Feb 05, 1980
GLUCOSE OXIDASE REAGENT KIT
K800070 · CGA
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Feb 05, 1980
BUN REAGENT KIT
K800071 · CDS
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Feb 05, 1980
TRANSCUTANEOUS OXYGEN MONITOR
K800073
Biochem International, Inc.
Cardiovascular · 22d
Cleared Feb 05, 1980
BRIOX MODEL-AEROMIST
K800078
Briox Technologies, Inc.
Cardiovascular · 22d
Cleared Feb 05, 1980
STORZ SUPER SORB MICRO EYE SPONGE
K800082 · EFQ
Storz Instrument Co.
General & Plastic Surgery · 22d
Cleared Feb 05, 1980
CHICK SURGICAL TABLE
K800118 · FWY
Warner-Lambert Co.
General & Plastic Surgery · 18d