FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
140521–140544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1987
VARIOUS TYPES OF SURGICAL GARMENTS
K870618 · FYF
Kin Yuh Hung Co., Ltd.
General & Plastic Surgery · 25d
Cleared Mar 09, 1987
LIFEWATCH PLUS
K870661 · BZQ
The Perkin-Elmer Corp.
Anesthesiology · 18d
Cleared Mar 09, 1987
DRIVER-BENDER-EXTRACTOR, BONE PIN
K870668 · HXW
Military Engineering, Inc.
Orthopedic · 18d
Cleared Mar 09, 1987
WARSAW ORTHOPEDIC I BONE PLATE
K870727 · KTW
Warsaw Orthopedic, Inc.
Orthopedic · 13d
Cleared Mar 09, 1987
ACROMED WALLIE-HEINIG CURETTES
K870778 · HTF
Buckman Co., Inc.
General & Plastic Surgery · 11d
Cleared Mar 09, 1987
ACROMED WALLIE-HEINIG TROCHAR
K870779 · HWJ
Buckman Co., Inc.
Orthopedic · 11d
Cleared Mar 09, 1987
ACROMED WALLIE-HEINIG OSTEOTOMES
K870780 · HWM
Buckman Co., Inc.
General & Plastic Surgery · 11d
Cleared Mar 09, 1987
ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS
K870781 · GEG
Buckman Co., Inc.
General & Plastic Surgery · 11d
Cleared Mar 06, 1987
EAZY COVERS
K863853 · JAA
Superior Medical Products
Radiology · 155d
Cleared Mar 06, 1987
V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540
K864507 · LDF
Spectramed, Inc.
Cardiovascular · 112d
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