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
175153–175176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1976
MODEL CNA-1 VAPORIZER
K761160 · CAD
Cyprane North America, Inc.
Anesthesiology · 10d
Cleared Dec 09, 1976
BRACHIAL PLEXUS BLOCK ANESTHESIA KIT
K761162 · CAZ
Arrow Intl., Inc.
Anesthesiology · 9d
Cleared Dec 09, 1976
TC-1 CARDIAC OUTPUT COMPUTER
K761166 · DXG
Waters Assoc., Inc.
Cardiovascular · 8d
Cleared Dec 09, 1976
ENEMA KIT
K761167 · FCE
American Hospital Supply Corp.
Gastroenterology & Urology · 8d
Cleared Dec 09, 1976
GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP
K761169 · DXC
Pilling Co.
Cardiovascular · 8d
Cleared Dec 09, 1976
ISOTONIC DILUENT AF
K761182 · GGK
Central Labs. Assoc. MD Pathologists
Hematology · 7d
Cleared Dec 09, 1976
HLR QUICK-FIT HEART-LUNG RESUSCITATOR
K761194 · DRM
Mckesson Corp.
Cardiovascular · 3d
Cleared Dec 09, 1976
ESOPHAGEAL OBTURATION AIRWAY
K761195 · CAO
Mckesson Corp.
Anesthesiology · 3d
Cleared Dec 09, 1976
MODEL 3044 3-CHANNEL STRESS TEST SYSTEM
K761198 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 3d
Cleared Dec 09, 1976
AQUA-SEAL
K761202 · KDQ
Respiratory Care, Inc.
General Hospital · 2d
Cleared Dec 09, 1976
TAXO DISCS FOR DIFF. OF ANAEROBES
K761209 · JTO
Bioquest
Microbiology · 2d
Cleared Dec 06, 1976
LITHOTRITE
K760273 · FGK
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 137d
Cleared Dec 06, 1976
RADIO IMMUNO ASSAY KIT/
K760619 · CDD
New England Nuclear
Chemistry · 84d
Cleared Dec 06, 1976
ADAPTER, FIBER OPTICS HEADLIGHT
K760647 · FCW
Pilling Co.
Gastroenterology & Urology · 82d
Cleared Dec 06, 1976
ADAPTER/STANDARD FIBER OPTICS LIGHT
K760653 · EQH
Pilling Co.
Ear, Nose, Throat · 81d
Cleared Dec 06, 1976
MULTI-PORTED FACE PLATE
K760654
Pilling Co.
Cardiovascular · 81d
Cleared Dec 06, 1976
DONORMATIC (BLOOD COLLECTION DEVICE)
K760743 · KSQ
Lifeline Instruments, Inc.
Hematology · 67d
Cleared Dec 06, 1976
TRIEX-1 HOLLOW FIBER DIALYZER
K760781 · FJT
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 62d
Cleared Dec 06, 1976
RUTNER UNIVERSAL WEDGE CATHETER
K760858 · KOD
Cook, Inc.
Gastroenterology & Urology · 49d
Cleared Dec 06, 1976
BEDSIDE CONSOLES (11-3-910 & 11-3-930)
K760965 · FKQ
Seattle Artificial Kidney Supply Co.
Gastroenterology & Urology · 32d
Cleared Dec 06, 1976
PAP-TRAY I (CATALOG #C600-1)
K761000 · LEA
Lerner Laboratories, Inc.
Pathology · 28d
Cleared Dec 06, 1976
PAP-TRAY II (CATALOG #C600-2)
K761001 · LEA
Lerner Laboratories, Inc.
Pathology · 28d
Cleared Dec 06, 1976
CARDIART 108T/313
K761014 · DPS
Conway Electronic Enterprises , Ltd.
Cardiovascular · 27d
Cleared Dec 06, 1976
SINGLE NEEDLE HEMODIALYSIS
K761038 · KOC
Sorensen Research
Gastroenterology & Urology · 21d