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
138937–138960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1987
HEARING AID (IN-THE-EAR)
K873070 · ESD
Central Illinois Hearing Aid Centers,...
Ear, Nose, Throat · 41d
Cleared Sep 15, 1987
BUNN CONCENTRATOR MODEL 2100 SERIES
K873071 · CAW
The John Bunn Co.
Anesthesiology · 41d
Cleared Sep 14, 1987
DIAGNOSTIC KIT FREE T3 AND FREE T4
K870268 · CEC
Sclavo, Inc.
Chemistry · 234d
Cleared Sep 14, 1987
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
K870923 · KWA
Protek, Inc.
Orthopedic · 194d
Cleared Sep 14, 1987
CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.
K870924 · KWA
Protek, Inc.
Orthopedic · 194d
Cleared Sep 14, 1987
AIS ANGIOSCOPE
K871492 · DQX
Advanced Interventional Systems, Inc.
Cardiovascular · 151d
Cleared Sep 14, 1987
FLEXIBLE URETEROSCOPE
K872282 · FGB
Intramed Laboratories, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 14, 1987
WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
K872378 · DTN
C.R. Bard, Inc.
Cardiovascular · 87d
Cleared Sep 14, 1987
ACA URINE DRUGS OF ABUSE CALIBRATOR
K872392 · DKB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 87d
Cleared Sep 14, 1987
SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE
K872472 · DXT
Angiomedics, Inc.
Cardiovascular · 83d
Cleared Sep 14, 1987
SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER
K872542 · LIT
Angiomedics, Inc.
Cardiovascular · 77d
Cleared Sep 14, 1987
ROTASCREEN
K872568 · GOB
Mercia Diagnostics , Ltd.
Microbiology · 77d
Cleared Sep 14, 1987
VIRON(TM)
K872646 · JJT
bioMerieux, Inc.
Chemistry · 70d
Cleared Sep 14, 1987
IAFP V. AGAR SELECTIVE
K872690 · JSJ
I.A.F. Production, Inc.
Microbiology · 69d
Cleared Sep 14, 1987
OSCAR(TM) PB255 OXIMETER CAPNOMETER
K872760 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 63d
Cleared Sep 14, 1987
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
K872916 · KPA
Fisher Scientific Co., LLC
Hematology · 52d
Cleared Sep 14, 1987
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE
K873033 · JHI
Serono Diagnostics, Inc.
Immunology · 41d
Cleared Sep 14, 1987
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
K873052 · CEP
American Dade
Chemistry · 41d
Cleared Sep 14, 1987
MICRO-READER II
K873138 · JJQ
Hyperion, Inc.
Chemistry · 35d
Cleared Sep 14, 1987
MODEL SI AND SP BEHIND-THE-EAR HEARING AID
K873376 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 21d
Cleared Sep 14, 1987
DAHLBERG MODEL MH BEHIND-THE-EAR HEARING AID
K873397 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 21d
Cleared Sep 14, 1987
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690
K873424 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Sep 14, 1987
S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS
K873455 · FJK
Dravon Medical, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 11, 1987
CHLAMYSET ANTIBODY EIA
K864457 · LJC
Orion Corp.
Microbiology · 303d