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
159337–159360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1982
SIREMOBILE 3
K827792
Siemens Medical Solutions USA, Inc.
Radiology · 19d
Cleared Aug 12, 1982
TOM'S NATURALLY WAXED FLOSSING TAPE
K821685 · JES
Tom'S of Maine, Inc.
Dental · 65d
Cleared Aug 12, 1982
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K821752 · LYC
Depuy, Inc.
Dental · 58d
Cleared Aug 12, 1982
EBV-VCA ANTIBODY ASSAY KIT
K821849 · JRY
Biotech Research Laboratories, Inc.
Microbiology · 50d
Cleared Aug 12, 1982
DANAVOS CUSTOM EAR
K821991 · ESD
Deravox, Inc.
Ear, Nose, Throat · 36d
Cleared Aug 12, 1982
SHILEY LARYNGECTOMY TUBE
K821993 · KAC
Shiley, Inc.
Ear, Nose, Throat · 36d
Cleared Aug 12, 1982
OPERATIVE EAR CURRETTES & RELATED ITEM
K822006 · JYG
Kelleher Corp.
Ear, Nose, Throat · 35d
Cleared Aug 12, 1982
BONE RONGEUNS ENT & RELATED ITEMS
K822007 · JZA
Kelleher Corp.
Ear, Nose, Throat · 35d
Cleared Aug 12, 1982
TORX OR TYPE MICRO MOTOR HANDPIECE
K822008 · ERL
Kelleher Corp.
Ear, Nose, Throat · 35d
Cleared Aug 12, 1982
RIGID SUCTION TIPS & RELATED ITEMS
K822010 · JZF
Kelleher Corp.
Ear, Nose, Throat · 35d
Cleared Aug 12, 1982
SHEA'S EAR SPECULUM HOLDER PORT MANNS
K822011 · JYK
Kelleher Corp.
General & Plastic Surgery · 35d
Cleared Aug 12, 1982
I.V. ADMINISTRATION SET
K822027 · FPA
Baker & Hostetler
General Hospital · 31d
Cleared Aug 12, 1982
GILCHEM Y-GT REAGENT
K822149 · JPZ
Gilford Diagnostics
Chemistry · 21d
Cleared Aug 12, 1982
PRIMIDONE FLUORESCENT IMMUNOASSAY
K822229 · LFT
American Diagnostic Corp.
Toxicology · 16d
Cleared Aug 12, 1982
CF 1211 CAPILLARY FLOW DIALYZER CODE
K822395 · FJH
Travenol Laboratories, S.A.
Gastroenterology & Urology · 1d
Cleared Aug 11, 1982
CEMENT-PICK
K822108 · GAF
Bio-Blitz, Inc.
General & Plastic Surgery · 23d
Cleared Aug 11, 1982
ENT RETRACTORS
K822163 · ESD
Kelleher Corp.
Ear, Nose, Throat · 19d
Cleared Aug 11, 1982
EAR SPECULI
K822164 · EPY
Kelleher Corp.
General & Plastic Surgery · 19d
Cleared Aug 10, 1982
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN
K821026 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 119d
Cleared Aug 10, 1982
SYSTEM ONE OXYGEN CONCENTRATOR
K821393 · CAW
Marathon
Anesthesiology · 91d
Cleared Aug 10, 1982
THE ARTIFICIAL URINARY SPHINCTER
K821627 · FAG
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Aug 10, 1982
THE INFLATABLE PENILE PROSTHESIS
K821628 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Aug 10, 1982
SURGITEK PERCUTANEOUS NEPHROST. STENT
K821776 · LJE
Medical Engineering Corp.
Gastroenterology & Urology · 54d
Cleared Aug 10, 1982
PIGTAIL NASAL CATHETERS
K821817 · FGE
American Endoscopy, Inc.
Gastroenterology & Urology · 50d