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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
109561–109584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1994
MODEL MPFT-01, GENESIS
K934574 · IXR
International Medical Designs, Inc.
Radiology · 169d
Cleared Mar 04, 1994
ENDOPATH ENDOSCOPIC ELECTROSURGICAL FORCEPS WITH CUTTING FEATURE
K934784 · GEI
Ethicon, Inc.
General & Plastic Surgery · 150d
Cleared Mar 04, 1994
OMRON MASSAGER MODEL HM-45
K935459 · ISA
Omron Healthcare, Inc.
Physical Medicine · 112d
Cleared Mar 04, 1994
OMBRON TWIN-HEAD MASSAGER MODEL HM-101
K935462 · ISA
Omron Healthcare, Inc.
Physical Medicine · 112d
Cleared Mar 04, 1994
OMRON MASSAGER MODEL HM-102
K935581 · ISA
Omron Healthcare, Inc.
Physical Medicine · 106d
Cleared Mar 04, 1994
MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
K935658 · LYA
Merocel Corp.
Ear, Nose, Throat · 100d
Cleared Mar 04, 1994
GC TEMPRON
K935960 · EBG
GC America, Inc.
Dental · 81d
Cleared Mar 04, 1994
PRIZM HEARING SYSTEM, MODEL POWER BTE
K936007 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 78d
Cleared Mar 04, 1994
SUREFIRE 10
K940282 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Mar 04, 1994
SILFREE 2 HIGH-PALLADIUM ALLOY FOR PORCELAIN APPLICATION
K940337 · EJT
Argen Precious Metals, Inc.
Dental · 38d
Cleared Mar 04, 1994
AUROLITE 1K
K940341 · EJT
Argen Precious Metals, Inc.
Dental · 38d
Cleared Mar 04, 1994
SUREFIRE W
K940342 · EJT
Argen Precious Metals, Inc.
Dental · 38d
Cleared Mar 04, 1994
AUROLITE 1B
K940343 · EJT
Argen Precious Metals, Inc.
Dental · 38d
Cleared Mar 04, 1994
AUROLITE 85
K940360 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Mar 03, 1994
OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
K930187 · JDI
Osteonics Corp.
Orthopedic · 413d
Cleared Mar 03, 1994
SUTURE NON-ABSORBABLE SILK
K931913 · GAP
Surgimetrics International, Ltd.
General & Plastic Surgery · 321d
Cleared Mar 03, 1994
STAINLESS STEEL SUTURE
K931915 · GAQ
Surgimetrics International, Ltd.
General & Plastic Surgery · 321d
Cleared Mar 03, 1994
SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER
K931916 · GAT
Surgimetrics International, Ltd.
General & Plastic Surgery · 321d
Cleared Mar 03, 1994
SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE
K931917 · GAW
Surgimetrics International, Ltd.
General & Plastic Surgery · 321d
Cleared Mar 03, 1994
CATGUT SUTURE PLAIN
K931918 · GAL
Surgimetrics International, Ltd.
General & Plastic Surgery · 321d
Cleared Mar 03, 1994
CATGUT SUTURE CHROMIC
K931919 · GAL
Surgimetrics International, Ltd.
General & Plastic Surgery · 321d
Cleared Mar 03, 1994
ISI(R) PORPOISE NOSE DISSECTING FORCEPS
K932695 · GCJ
Innovative Surgical, Inc.
General & Plastic Surgery · 273d
Cleared Mar 03, 1994
ISI(R) CURVED, TAPERED DISSECTING FORCEPS
K932696 · GCJ
Innovative Surgical, Inc.
General & Plastic Surgery · 273d
Cleared Mar 03, 1994
CEEGRAPH, MODIFICATION
K933233 · GWQ
Bio-Logic Systems Corp.
Neurology · 316d