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
126745–126768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1990
CUSTOM TRAYS, KITS
K894610 · FSM
L H M Ent., Inc.
General & Plastic Surgery · 238d
Cleared Mar 15, 1990
PLATELIA TOXO IGM KIT
K894948 · LGD
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 224d
Cleared Mar 15, 1990
CHEMO-TOUCH
K895195 · LZC
Medical Resources, Ltd.
General Hospital · 216d
Cleared Mar 15, 1990
WIDEX HEARING AID MODELS ES9T AND ES9H
K895981 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 154d
Cleared Mar 15, 1990
WIDEX HEARING AID MODEL ES 10 ASP T
K895982 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 154d
Cleared Mar 15, 1990
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
K896174 · GGP
Helena Laboratories
Hematology · 141d
Cleared Mar 15, 1990
MODEL 404A I.V. INFUSION PUMP ANALYZER
K897096 · FRN
Dynatech/Nevada, Inc.
General Hospital · 84d
Cleared Mar 15, 1990
THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
K897144 · KLI
Medix Biotech, Inc.
Chemistry · 78d
Cleared Mar 15, 1990
OLYMPUS DIRECT BILIRUBIN
K897175 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Mar 15, 1990
NON-ELECTRIC BIOPSY FORCEPS
K900015 · FCL
Esco Precision, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 15, 1990
BJ STAR ALL SILICONE FOLEY BALLOON CATHETER
K900022 · KOD
B.J. Star, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 15, 1990
NON-ELECTRIC BIOPSY FORCEPS
K900065 · FCL
Esco Precision, Inc.
Gastroenterology & Urology · 70d
Cleared Mar 15, 1990
TCPM II TOURNIQUET CUFF PRESSURE MONITOR
K900104 · KCY
Electromedics, Inc.
General & Plastic Surgery · 65d
Cleared Mar 15, 1990
VENOJECT II BLOOD COLLECTION TUBES
K900309 · JKA
Terumo Medical Corp.
Chemistry · 52d
Cleared Mar 15, 1990
ORTHOKROME* FACTOR VIII
K900395 · GGP
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* HEPARIN
K900396 · KFF
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* ANTIPLASMIN
K900397 · GGP
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* PROTEIN C
K900398 · GGP
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* PLASMINOGEN
K900399 · GGP
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* ANTITHROMBIN
K900400 · JBQ
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ABIOMED BODY LEAD ANALYZER MODEL 200/20
K900574 · JAO
Abiomed, Inc.
Radiology · 36d
Cleared Mar 15, 1990
ANESTHESIA BREATHING CIRCUIT
K900594 · CAI
Inhalation Plastics
Anesthesiology · 36d
Cleared Mar 15, 1990
RESPIREX 2
K900754 · BWF
Diemolding Corp.
Anesthesiology · 27d
Cleared Mar 15, 1990
ENZYMUN TEST(R) FSH
K900763 · CGJ
Boehringer Mannheim Corp.
Chemistry · 27d