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

Filters: Cleared only ×
175,820 results
141121–141144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1987
P.C.A. MODULAR KNEE SYSTEM
K864632 · JWH
Howmedica Corp.
Orthopedic · 101d
Cleared Mar 06, 1987
L.A.P. SPIROMETER
K864836 · BTY
Timeter Instrument Corp.
Anesthesiology · 87d
Cleared Mar 06, 1987
RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL
K864886 · BZK
Nims/Respitrace Corp.
Anesthesiology · 84d
Cleared Mar 06, 1987
OMNI-TRAK
K864889 · DSB
Invivo Research Labs, Inc.
Cardiovascular · 84d
Cleared Mar 06, 1987
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM
K865036 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 73d
Cleared Mar 06, 1987
ASPARTATE AMINOTRANSFERASE (AST)/(GOT)
K870077 · CIT
Catachem, Inc.
Chemistry · 57d
Cleared Mar 06, 1987
ALANINE AMINOTRANSFERASE (ALT)/(GPT)
K870086 · CKA
Catachem, Inc.
Chemistry · 57d
Cleared Mar 06, 1987
BUNN MODEL 530 ASPIRATOR
K870094 · BTA
The John Bunn Co.
General & Plastic Surgery · 56d
Cleared Mar 06, 1987
1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE
K870138 · CBP
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 52d
Cleared Mar 06, 1987
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
K870170 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Mar 06, 1987
ROTAX-II BI-PLANE CIRCULAR ARM
K870205
B C Medical , Ltd.
Radiology · 45d
Cleared Mar 06, 1987
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR
K870253 · CBP
Intertech Resources, Inc.
Anesthesiology · 43d
Cleared Mar 06, 1987
DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011
K870382 · CBP
Nova-Ventrx
Anesthesiology · 36d
Cleared Mar 06, 1987
SELVERSTONE CLAMP SALIBI CLAMP
K870399 · HCE
Codman & Shurtleff, Inc.
Neurology · 32d
Cleared Mar 06, 1987
WAKO(TM) AUTOKIT LDH
K870401 · CFJ
Wako Chemicals USA, Inc.
Chemistry · 32d
Cleared Mar 06, 1987
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
K870461 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Mar 06, 1987
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500 · JIL
American Diagnostic Corp.
Chemistry · 30d
Cleared Mar 06, 1987
SUPER URINE ANALYZER SYSTEM
K870526 · KQO
Kyoto Daiichi Kagaku Co., Ltd.
Chemistry · 28d
Cleared Mar 06, 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
K870553 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Mar 06, 1987
GLUCOSE OXIDASE REAGENT
K870616 · CGA
Intersect Systems, Inc.
Chemistry · 22d
Cleared Mar 06, 1987
MICROBOND COMPOSITE KIT FOR CERAMIC BONDING SYSTEM
K870628 · EBF
Chem-E-Dent
Dental · 21d
Cleared Mar 06, 1987
OTOLOGICAL METRIC SCALE/GAUGE
K870757
Treace Medical, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 06, 1987
EAR APPLICATOR, CATALOG NO. 2229
K870762 · KXF
Treace Medical, Inc.
General Hospital · 8d
Cleared Mar 05, 1987
KIDNEY PERFUSION MACHINE
K864140 · KDN
Advanced Equipment Development, Inc.
Gastroenterology & Urology · 135d