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
130897–130920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1989
ND1100 BONE DENSITY SCANNER
K881383 · KGI
Nuclear Data, Inc.
Radiology · 416d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVE
K890592 · LYY
Alfaseal Sdn. Bhd.
General Hospital · 105d
Cleared May 22, 1989
COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
K890618 · CEK
Kenlor Industries, Inc.
Chemistry · 104d
Cleared May 22, 1989
DUPONT DISTAL HUMERAL NAIL
K890939 · HRS
Howmedica Corp.
Orthopedic · 87d
Cleared May 22, 1989
OXITRON OXYGEN ANALYZER
K890958 · CCL
Oxitron Medical Products
Anesthesiology · 84d
Cleared May 22, 1989
COAG-1 APTT TEST CARD
K891015 · GFO
Cardiovascular Diagnostic Services
Hematology · 83d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891177 · LYY
Garrett-Hewitt Intl., Inc.
General Hospital · 77d
Cleared May 22, 1989
ROCHE(R) CARDIOSCREEN-CK
K891462 · CGS
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared May 22, 1989
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891468 · CIT
Trace Scientific , Ltd.
Chemistry · 68d
Cleared May 22, 1989
YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER
K891480 · CGA
Yellow Springs Instrument Co., Inc.
Chemistry · 66d
Cleared May 22, 1989
AVL MODEL 987 ELECTROLYTE ANALYZER
K891578 · CHL
Avl Scientific Corp.
Chemistry · 63d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891638 · LYY
Tak Ent., Inc.
General Hospital · 66d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)(POWDERED)
K891640 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 66d
Cleared May 22, 1989
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968 · LZC
Boston Scientific Corp
General Hospital · 54d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892093 · LYY
Wah Chiang Ent. Sdn Bhd
General Hospital · 49d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892103 · LYY
Jenq Chuam Industrial Co., Ltd.
General Hospital · 49d
Cleared May 22, 1989
DRI-DYE CHECK STRIPS (TM)-405
K892656 · JJX
Awareness Technology, Inc.
Chemistry · 39d
Cleared May 22, 1989
NON-STERILE PATIENT EXAMINATION GLOVES (LATEX)
K892747 · LYY
Asia Way Trading, Inc.
General Hospital · 41d
Cleared May 22, 1989
ARGEDENT 45
K892814 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared May 22, 1989
AUTOTRANSFUSION DEVICE
K892819 · CAC
Impra, Inc.
Anesthesiology · 35d
Cleared May 22, 1989
T4 CLASP-BEAD EIA KIT
K892853 · KLI
Biotecx Laboratories, Inc.
Chemistry · 34d
Cleared May 22, 1989
ACA VANCOMYCIN (VANC) METHOD
K892900 · LEH
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 32d
Cleared May 22, 1989
ARGELITE 80SF+ DENTAL ALLOY
K892909 · EJT
Argen Precious Metals, Inc.
Dental · 32d
Cleared May 22, 1989
AMNIO-GROW TM
K892938 · KIT
Inovar Biologicals, Inc.
Pathology · 31d