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
133873–133896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1988
STERNAL POWER AWL
K873766 · KIJ
Bowen & Company, Inc.
Orthopedic · 425d
Cleared Nov 14, 1988
NEEDLE REMOVER
K881866 · FMF
Howard, Hills & Harsh
General Hospital · 195d
Cleared Nov 14, 1988
FLUIDAIR
K881917 · INX
Kinetic Concepts, Inc.
Physical Medicine · 189d
Cleared Nov 14, 1988
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
K882391 · DXY
Ela Medical, Inc.
Cardiovascular · 157d
Cleared Nov 14, 1988
FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE
K883120 · EJF
Flexmedics
Dental · 111d
Cleared Nov 14, 1988
DONALDSON VENTILATION TUBES PT. # AG/S9
K883667 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 80d
Cleared Nov 14, 1988
FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS
K883705 · FXX
Select Sources, Inc.
General Hospital · 76d
Cleared Nov 14, 1988
TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM
K883756 · LNH
Toshiba Medical Systems
Radiology · 69d
Cleared Nov 14, 1988
VAS-CATH CATHETER REPAIR KIT
K883768 · LFJ
Vas-Cath, Inc.
Gastroenterology & Urology · 69d
Cleared Nov 14, 1988
H.A.C. MODEL-A (ALL IN THE EAR)
K883772 · ESD
Hearing Aid Crafters
Ear, Nose, Throat · 69d
Cleared Nov 14, 1988
H.A.C. MODEL-B (ALL IN THE CANAL)
K883773 · ESD
Hearing Aid Crafters
Ear, Nose, Throat · 69d
Cleared Nov 14, 1988
WALLABY(TM) BLANKET
K883779 · LBI
Fiberoptic Medical Products, Inc.
General Hospital · 69d
Cleared Nov 14, 1988
C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR
K884086 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 48d
Cleared Nov 14, 1988
HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET
K884156 · FPK
Sechrist Industries, Inc.
General Hospital · 41d
Cleared Nov 14, 1988
HIGH RISK NEEDLE CONNECTOR ASSEMBLY
K884264 · FPA
Venture Molded Products, Inc.
General Hospital · 34d
Cleared Nov 14, 1988
PREMIER DIE-TRAK ARTICULATOR
K884418 · EJP
Premier Medical
Dental · 25d
Cleared Nov 14, 1988
STAMEY NEEDLE
K884553 · GEJ
Cook Ob/Gyn
General & Plastic Surgery · 14d
Cleared Nov 14, 1988
TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS
K884584 · BWB
Eastmed Enterprises, Inc.
Anesthesiology · 12d
Cleared Nov 10, 1988
CREATINE KINASE (CK) ISOENZYME MB
K881168 · JHT
Data Medical Associates, Inc.
Chemistry · 237d
Cleared Nov 10, 1988
PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE
K881426 · NAD
Laboratoire Pan-Pra
General & Plastic Surgery · 219d
Cleared Nov 10, 1988
HYGEIA URINE PREGNANCY TEST
K882192 · DHA
Hygeia Sciences
Chemistry · 169d
Cleared Nov 10, 1988
TURBOX THEOPHYLLINE ASSAY
K882570 · LER
Unipath , Ltd.
Toxicology · 141d
Cleared Nov 10, 1988
KODAK SURECELL CHLAMYDIA TEST KIT
K882923 · LJC
Eastman Kodak Company
Microbiology · 120d
Cleared Nov 10, 1988
SATURNE 42 AND 43
K883019 · IYE
General Electric Co.
Radiology · 114d