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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145033–145056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1986
VAN-TEC DEFLECTING GRASPING FORCEPS
K860268 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 66d
Cleared Apr 03, 1986
TI-FIT ACETABULAR COMPONENT
K860275 · LZO
Richards Medical Co., Inc.
Orthopedic · 66d
Cleared Apr 03, 1986
A-GENT LIQUID TOTAL BILIRUBIN
K860424 · CIG
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
A-GENT LIQUID CALCIUM
K860425 · CIC
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
A-GENT LIQUID TOTAL PROTEIN
K860426 · CEK
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
URIC ACID REAGNET SET (TRINDER)
K860477 · KNK
Sterling Diagnostics, Inc.
Chemistry · 55d
Cleared Apr 03, 1986
SGPT (ALT) REAGENT SET (COLORIMETRIC)
K860485 · CKD
Sterling Diagnostics, Inc.
Chemistry · 52d
Cleared Apr 03, 1986
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
K860641 · DLI
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 03, 1986
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
K860667 · CIT
Sterling Diagnostics, Inc.
Chemistry · 38d
Cleared Apr 03, 1986
DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID
K860671 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 38d
Cleared Apr 03, 1986
ANALYTE IRON/TECHNICON CHEM 1 SYSTEM
K860799 · JIY
Technicon Instruments Corp.
Chemistry · 30d
Cleared Apr 03, 1986
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN
K860868 · LCD
Technicon Instruments Corp.
Chemistry · 27d
Cleared Apr 03, 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Apr 03, 1986
DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER
K860946 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 22d
Cleared Apr 03, 1986
PRECINORM IM AND PRECIPATH IM
K860970 · JJY
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Apr 03, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED
K860998 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 16d
Cleared Apr 03, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED
K861000 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 16d
Cleared Apr 03, 1986
ISOLIFE DISPENSING SYSTEM
K861051 · KNT
Navaco Laboratories
Gastroenterology & Urology · 15d
Cleared Apr 02, 1986
MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4
K853216 · HHK
Gyneco, Inc.
Obstetrics & Gynecology · 244d
Cleared Apr 02, 1986
ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE
K860246 · PUP
Buckman Co., Inc.
General Hospital · 68d
Cleared Apr 02, 1986
STABLELINE
K860298 · KRI
Cardio Metrics, Inc.
Cardiovascular · 64d
Cleared Apr 02, 1986
RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES
K860699 · DQY
Intracath, Inc.
Cardiovascular · 36d
Cleared Apr 02, 1986
ULTRAPROX, INTERPROXIMAL TOOTHBRUSH
K860779 · JET
William J. Forni, D.D.S.
Dental · 30d
Cleared Apr 02, 1986
PLASTIC MOUTH BARRIER HCV-E
K860780 · CAE
Westmark Enterprises, Inc.
Anesthesiology · 30d