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
153961–153984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1984
SELECTIVE AND DIFFERENTIAL
K841209 · JSI
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
CAMPYLOBACTER THIOGLYCOLLATE MED
K841303 · JSG
Anaerobe Systems
Microbiology · 18d
Cleared Apr 17, 1984
HAEMOPHILUS ID QUAD-PLATE
K841304 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 18d
Cleared Apr 17, 1984
MOUTH TO MASK EMERGENCY VENTILATION
K841429 · CAE
O-Two Systems Intl., Inc.
Anesthesiology · 11d
Cleared Apr 16, 1984
OBSTETRIC PULSAR TWO CHANNEL TENS
K840497 · GZJ
Spembly Medical , Ltd.
Neurology · 70d
Cleared Apr 16, 1984
DAYPAK SYSTEM III CATHETER CARE KIT
K840681 · LJS
Creative Care Systems, Inc.
General Hospital · 61d
Cleared Apr 16, 1984
PROVIDER SITE PREP & CHECK STRIP KIT
K841027 · FPA
Pancretec, Inc.
General Hospital · 35d
Cleared Apr 13, 1984
C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
K833396 · JKD
Serono Diagnostics, Inc.
Chemistry · 196d
Cleared Apr 13, 1984
THERMO SENTRY 1200 THERMO-SYS-TS1200
K833711 · FLL
Clini-Therm Corp.
General Hospital · 176d
Cleared Apr 13, 1984
PROVIDER U-100 INSULIN INFUSION SYS
K833983 · FRN
Pancretec, Inc.
General Hospital · 148d
Cleared Apr 13, 1984
CRITERION I
K834274 · CAW
Timeter Instrument Corp.
Anesthesiology · 127d
Cleared Apr 13, 1984
TECHNICARE 280
K834486 · IYO
Technicare Corp.
Radiology · 128d
Cleared Apr 13, 1984
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID
K834505 · JJR
Quantimetrix Corp.
Chemistry · 114d
Cleared Apr 13, 1984
HEMODIAL CONCENTRATE
K834587 · FKQ
Moana Productions, Inc.
Gastroenterology & Urology · 106d
Cleared Apr 13, 1984
RHINOTHERM
K840118 · KFZ
Ascot Pharmaceuticals, Inc.
Anesthesiology · 93d
Cleared Apr 13, 1984
ESTIC MICROFILL
K840176 · EBF
Kulzer, Inc.
Dental · 87d
Cleared Apr 13, 1984
VISTECH VCTS 6000
K840255 · HOX
Vistech Consultants, Inc.
Ophthalmic · 81d
Cleared Apr 13, 1984
MULTIPLE BAG, LEG
K840283 · KNX
Luth Corp.
Gastroenterology & Urology · 86d
Cleared Apr 13, 1984
MULTIPLE SYS-URINE DRAINAGE-CLOSED
K840284 · KNX
Luth Corp.
Gastroenterology & Urology · 86d
Cleared Apr 13, 1984
CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY
K840334 · FMI
Applied Medical Devices, Inc.
General Hospital · 79d
Cleared Apr 13, 1984
OVU STICK URINE HLH KIT
K840412 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 73d
Cleared Apr 13, 1984
SUN-LITE ONE MILLIMETER
K840429
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 73d
Cleared Apr 13, 1984
SUN-LITE 1
K840456
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 71d
Cleared Apr 13, 1984
NORMAL CLINICAL CHEM. CONTROL SERUM-
K840457 · JJY
Otisville Biotech, Inc.
Microbiology · 71d