FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127345–127368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 15, 1990
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
K900821 · LRG
Bd Becton Dickinson Vacutainer...
Microbiology · 22d
Cleared Mar 15, 1990
MJ PERCUSSOR(TM)
K901026 · BYI
Merced Medical, Inc.
Anesthesiology · 9d
Cleared Mar 14, 1990
HEARING AID (ALL-IN-THE-EAR)
K893004 · ESD
Hearing Specialists of Nevada, Inc.
Ear, Nose, Throat · 324d
Cleared Mar 14, 1990
SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH
K895017 · DXG
Sorba Medical Systems, Inc.
Cardiovascular · 218d
Cleared Mar 14, 1990
S-ROM/NOILES MARK 3
K896048 · KRO
Joint Medical Products Corp.
Orthopedic · 147d
Cleared Mar 14, 1990
ONCOPROBE II SYSTEM
K896588 · IZD
Care Wise Medical Products Corp.
Radiology · 113d
Cleared Mar 14, 1990
TD-28 DISPOSABLE ELECTRODE
K896766 · GXY
Med USA
Neurology · 103d
Cleared Mar 14, 1990
ALL-BOND DENTIN BONDING SYSTEM
K897020 · KLE
Bisco, Inc.
Dental · 85d
Cleared Mar 14, 1990
TEETHMATE-A
K897027 · EBC
Kuraray Co.
Dental · 86d
Cleared Mar 14, 1990
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
K897101 · EFB
Dentsply Intl.
Dental · 83d