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

Filters: Cleared only ×
175,820 results
111553–111576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1994
RADIATION TREATMENT FOR CANCER PATIENTS
K930182 · IYE
Northwest Medical Physics Center
Radiology · 356d
Cleared Jan 05, 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
K932095 · LJT
Pharmacia Deltec, Inc.
General Hospital · 250d
Cleared Jan 05, 1994
PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM
K932840 · LJT
Pharmacia Deltec, Inc.
General Hospital · 208d
Cleared Jan 05, 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS
K932841 · LJT
Pharmacia Deltec, Inc.
General Hospital · 208d
Cleared Jan 05, 1994
CELL SAVER 5 SYSTEM
K932890 · CAC
Haemonetics Corp.
Anesthesiology · 205d
Cleared Jan 05, 1994
XOMED-TREACE RIGID ROD LENS ENDOSCOPE
K933105 · EOB
Xomed-Treace, Inc.
Ear, Nose, Throat · 194d
Cleared Jan 05, 1994
3M VITREMER LUTING CEMENT
K933139 · EMA
3M Company
Dental · 191d
Cleared Jan 05, 1994
MYERSON'S PERMASOFT SOFT RELINE MATERIAL
K933468 · EBI
Austenal, Inc.
Dental · 173d
Cleared Jan 05, 1994
MAGNASHIELD CPR MOUTH BARRIER
K933756 · CBP
Cal West Trading Co.
Anesthesiology · 155d
Cleared Jan 05, 1994
STERIBASE (ACCUBASE)
K933999 · EJK
Centrix, Inc.
Dental · 141d
Cleared Jan 05, 1994
IMPAX 5000
K934386 · LMD
Heraeus Kulzer, Inc.
Radiology · 119d
Cleared Jan 05, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
K934719 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 96d
Cleared Jan 05, 1994
SCIMED MAVERICK
K934793 · LIT
Scimed Peripheral Interventions
Cardiovascular · 91d
Cleared Jan 05, 1994
LC DENTAL HAND INSTRUMENT
K935217 · EKJ
L.C. Dental
Dental · 71d
Cleared Jan 05, 1994
AUDIPHON, MODEL H-11
K935458 · ESD
National Hearing Aid Dist., Inc.
Ear, Nose, Throat · 54d
Cleared Jan 05, 1994
WILEY/ESPOSITO DENTAL GUARD
K935713 · BRW
Fvtnks
Anesthesiology · 36d
Cleared Jan 03, 1994
ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT
K921868 · CFL
Endocrine Sciences Products
Chemistry · 623d
Cleared Jan 03, 1994
FLOATS SUNGLASSES
K932151 · HQY
Floats, Inc.
Ophthalmic · 244d
Cleared Jan 03, 1994
ERCP CATHETER, HYDROPHILIC COATED
K932205 · GBX
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 242d
Cleared Jan 03, 1994
SPECTACLE FRAMES
K932439 · HQZ
Styl-Rite Optics, Inc.
Ophthalmic · 229d
Cleared Jan 03, 1994
MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER
K933020 · EYB
Boston Scientific Corp
Gastroenterology & Urology · 195d
Cleared Jan 03, 1994
CUDA PRODUCTS CORP. LIGHTSOURCES
K933369 · FCW
Cuda Products Co.
Gastroenterology & Urology · 178d
Cleared Jan 03, 1994
NONREBREATHING VALVE
K933583 · KGB
Hans Rudolph, Inc.
Anesthesiology · 164d
Cleared Jan 03, 1994
SIGMA ELECTROLYTE REFERENCE REAGENT
K933696 · JFL
Sigma Chemical Co.
Chemistry · 158d