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
173617–173640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1977
PORT-A-BATH
K770294 · ILK
Kathco, Inc.
Physical Medicine · 44d
Cleared Mar 30, 1977
COLON IRRIGATION DEV.,COLON-A-SUN COLONI
K770300 · FCE
Sun Product Dist., Inc.
Gastroenterology & Urology · 43d
Cleared Mar 30, 1977
GLUCOSE REAGENT, ENZYMATIC
K770311 · CFR
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Mar 30, 1977
REAGENT GPT, ENZYME
K770314 · CKA
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Mar 30, 1977
ALKALINE PHOSPHATASE ENZYMATIC
K770316 · CJE
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Mar 30, 1977
GLUCOSE TRINDER, ENZYMATIC
K770317 · CGA
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Mar 30, 1977
STYLETTE, SLICK, CAT. NO. 2000B
K770374 · BSR
Medical Products Div. P.O.L.A. Plasti
Anesthesiology · 33d
Cleared Mar 30, 1977
THROMBO-SCREEN AT-111 KIT
K770394 · JBQ
Bay Area Hema. Onco. Clinic. & Res. L
Hematology · 30d
Cleared Mar 30, 1977
SUMP DRAIN, W/FILTER, ARGYLE EDLICH
K770442 · GBX
Sherwood Medical Industries
General & Plastic Surgery · 23d
Cleared Mar 30, 1977
CITADEL REFERENCE ELECTRODE
K770477 · DRF
Sherwood Medical Industries
Cardiovascular · 19d
Cleared Mar 30, 1977
ADAPTER, CORDIS
K770478 · DTD
Cordis Corp.
Cardiovascular · 19d
Cleared Mar 30, 1977
LOUISVILLE CLAMP PRODUCT #65-172
K770503 · DXC
Edward Weck, Inc.
Cardiovascular · 14d
Cleared Mar 30, 1977
CANNULA, INTRAVENOUS, R
K770512 · DQR
Sherwood Medical Industries
Cardiovascular · 13d
Cleared Mar 30, 1977
MEMBRANE SOURCE-EX SERIES DIALYZER CART.
K770516 · KNX
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 12d
Cleared Mar 30, 1977
CATHETER, GRUNTZIG, BALLON
K770522 · DYG
Cook, Inc.
Cardiovascular · 12d
Cleared Mar 30, 1977
TRANSDUCER PROTECTOR, RT-901, RT-902
K770524 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 12d
Cleared Mar 30, 1977
PEDIATRIC ANESTHESIA CIRCUIT
K770549 · CAI
Inspiron Corp.
Anesthesiology · 9d
Cleared Mar 30, 1977
CATHETER, KIDNEY DIALYSIS, HEMO-CATH II
K770552 · KOC
Medical Disposables Intl., Inc.
Gastroenterology & Urology · 9d
Cleared Mar 30, 1977
NARKOMED ANESTHESIA MACHINE
K770554 · BSZ
Draeger Medical, Inc.
Anesthesiology · 9d
Cleared Mar 30, 1977
TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS
K770571 · CAZ
Travenol Laboratories, S.A.
Anesthesiology · 5d
Cleared Mar 30, 1977
ACTA-SCANNER R 0200FS
K770573 · JAK
Pfizer Medical Systems, Inc.
Radiology · 5d
Cleared Mar 29, 1977
ELECTROCARDIOGRAPHIC ELECTRODES, DISP.
K770521 · DRX
Dobre, Inc.
Cardiovascular · 11d
Cleared Mar 28, 1977
ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)
K761289 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 98d
Cleared Mar 28, 1977
TEMP. PERVENOUS LEAD W/REMOTE ANODE
K770214 · DTB
Cordis Corp.
Cardiovascular · 54d