FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90889–90912 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEM
K974463 · MOB
Immuno Concepts, Inc.
Immunology · 75d
Cleared Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEMS
K974478 · MOB
Immuno Concepts, Inc.
Immunology · 75d
Cleared Feb 09, 1998
NTL-FLOW
K974483 · EBF
Bisco, Inc.
Dental · 75d
Cleared Feb 09, 1998
MODIFIED URETERAL INDWELLING CATHETER/STENT
K974541 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 68d
Cleared Feb 09, 1998
ALLERGEN IMMUNOCAP F256,F245,F207,F202
K974580 · DHB
Pharmacia & Upjohn Co.
Immunology · 63d
Cleared Feb 09, 1998
ENCORE MARK IV POWDER FREE SURGICAL GLOVES
K974783 · KGO
Ansell Perry
General Hospital · 49d
Cleared Feb 09, 1998
LATEX (POWDER FREE) LOW PROTEIN
K974853 · LYY
P.T. Healthcare Glovindo
General Hospital · 42d
Cleared Feb 09, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K980037 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 35d
Cleared Feb 09, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 35d
Cleared Feb 09, 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K980039 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 35d
Cleared Feb 09, 1998
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
K980130 · CHL
Radiometer America, Inc.
Chemistry · 26d
Cleared Feb 09, 1998
POWDER-FREE NITRILE EXAMINATION GLOVES
K980150 · LZA
Masju Sdn. Bhd.
General Hospital · 24d
Cleared Feb 09, 1998
MANAN BILIARY DRAINAGE CATHETER
K980191 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 06, 1998
PRECISION FLOW OSV II
K971799 · JXG
Elekta Implants, SA
Neurology · 267d
Cleared Feb 06, 1998
PEBA ANCHOR/SUTURE COMBINATION
K972326 · MBI
Orthopaedic Biosystems, Ltd.
Orthopedic · 228d
Cleared Feb 06, 1998
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
K972740 · KFM
Himex Production Corp.
Cardiovascular · 199d
Cleared Feb 06, 1998
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
K972906 · GZB
Medtronic Vascular
Neurology · 184d
Cleared Feb 06, 1998
AMPLAID MK22
K972959 · GWF
Amplifon S.P.A.
Neurology · 179d
Cleared Feb 06, 1998
THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
K973669 · MCW
Micro Therapeutics, Inc.
Cardiovascular · 134d
Cleared Feb 06, 1998
PERIOPERATIVE DATA MANAGEMENT SYSTEM
K973949 · BSZ
Draeger Medical, Inc.
Anesthesiology · 113d
Cleared Feb 06, 1998
DATEX-ENGSTROM NETWORK
K974101 · MSX
Datex-Engstrom, Inc.
Cardiovascular · 99d
Cleared Feb 06, 1998
ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
K974199 · LOS
Marquette Medical Systems, Inc.
Cardiovascular · 88d
Cleared Feb 06, 1998
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
K974205 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 88d
Cleared Feb 06, 1998
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
K974209 · LCJ
Specialty Surgical Products, Inc.
General & Plastic Surgery · 88d