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
152185–152208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1984
DISPOSABLE LAPAROTOMY SPONGE
K843037
Anago, Inc.
General & Plastic Surgery · 34d
Cleared Sep 05, 1984
TCA HEARING AID
K843067 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 05, 1984
UTILITY SCISSORS DISPOSABLE ITEMS
K843075 · JOK
Greene International Corp.
General Hospital · 30d
Cleared Sep 05, 1984
CORMED HUBER POINT NEEDLE
K843083 · GAA
Cormed, Inc., Sub. C.R.Bard, Inc.
General & Plastic Surgery · 30d
Cleared Sep 05, 1984
APR MOBILE
K843192 · IZL
Philips Medical Systems (Cleveland),...
Radiology · 22d
Cleared Sep 05, 1984
CLINITRON AIR FLUIDIZED SUPPORT J-101UD
K843389 · INX
Uhi Corp.
Physical Medicine · 7d
Cleared Sep 04, 1984
TELECTRONICS MODEL 2401
K831697 · DTC
Seamed Corp.
Cardiovascular · 468d
Cleared Sep 04, 1984
CORNING MAGIC CORTISOL RADIOIMMUNO
K841641 · CGR
Corning Medical & Scientific
Chemistry · 137d
Cleared Sep 04, 1984
CT 9800
K841997 · JAK
General Electric Co.
Radiology · 111d
Cleared Sep 04, 1984
CHEMISTRY CONSOLE
K842401 · JQP
Biovation, Inc.
Chemistry · 77d
Cleared Sep 04, 1984
LH RIA
K842445 · CEP
Syncor Intl. Corp.
Chemistry · 75d
Cleared Sep 04, 1984
CLARK PRECISION BLOCK CUTTER, COOLING
K842615 · IXI
Clark Research and Development, Inc.
Radiology · 61d
Cleared Sep 04, 1984
ACE UNIVERSAL TONG
K842680 · HAX
Buckman Co., Inc.
Neurology · 56d
Cleared Sep 04, 1984
LABSYSTEMS FP-901 CHEMISTRY ANALYZER
K842773 · JJE
Labsystems, Inc.
Chemistry · 50d
Cleared Sep 04, 1984
PERCUFIX CATHETER CUFF
K842890 · KOD
Medi-Tech, Inc.
Gastroenterology & Urology · 43d
Cleared Sep 04, 1984
AMERLEX-M TSH RIA
K842948 · JLW
Amersham Corp.
Chemistry · 40d
Cleared Sep 04, 1984
CARDIONOSTICS HOLTER DURA-LITE RECORDE
K842954 · DSH
Cardionostics, Inc.
Cardiovascular · 39d
Cleared Sep 04, 1984
ION SELECTIVE ELECTRODES & REAGENT SYS
K843008 · CEM
American Monitor Corp.
Chemistry · 35d
Cleared Sep 04, 1984
BILIRUBIN ASSAY KIT DIRECT
K843027 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Sep 04, 1984
BILIRUBIN ASSAY KIT - TOTAL
K843032 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Sep 04, 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · JIS
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Sep 04, 1984
CRITIKON HEPARIN-COATED CARDIOVASCULAR
K843141 · LDF
Critikon Company, LLC
Cardiovascular · 26d
Cleared Sep 04, 1984
ND. YAG LASER FOR ENDOBRONCHIAL OBSTRUC
K843228
Endo Lase, Inc.
Cardiovascular · 19d
Cleared Sep 04, 1984
VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC
K843230 · JFH
Ventrex Laboratories, Inc.
Immunology · 18d