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
104977–105000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1994
IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT...
K933410 · IWJ
Best Industries
Radiology · 533d
Cleared Dec 30, 1994
PELVIC EXAM TRAY
K934732 · HHT
Medcare Custom Packaging, Inc.
Obstetrics & Gynecology · 457d
Cleared Dec 30, 1994
AN-10S ANDERSEN TUBE WITH STYLET
K935688 · BSS
H.W. Andersen Products, Inc.
Gastroenterology & Urology · 396d
Cleared Dec 30, 1994
ROYAL MARSDEN GOLD GRAIN GUN
K940119 · IWS
Best Industries
Radiology · 354d
Cleared Dec 30, 1994
IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS
K940121 · IWJ
Best Industries
Radiology · 354d
Cleared Dec 30, 1994
ELECTROSURGICAL LOOP ELECTRODE
K940191 · HGI
National Wire & Stamping, Inc.
Obstetrics & Gynecology · 351d
Cleared Dec 30, 1994
THERA-FLOW GRADIENT SEQUENTIAL PUMP
K943392 · JOW
Meds Systems, Inc.
Cardiovascular · 169d
Cleared Dec 30, 1994
ENTERAL DELIVERY SETS WITH HYDRATION PORT
K943675 · KNT
Clintec Technologies, Inc.
Gastroenterology & Urology · 157d
Cleared Dec 30, 1994
2D,3D, TOF MR ANGIOGRAPHY
K943800 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 149d
Cleared Dec 30, 1994
R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102
K944294 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 119d
Cleared Dec 30, 1994
R&D BATTERIES PART NOS. 5354 AND 5150
K944386 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 114d
Cleared Dec 30, 1994
ENDOSCOPE
K944555 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 105d
Cleared Dec 30, 1994
ORION PPM, PP, PP-D
K944777 · ESD
Rexton, Inc.
Ear, Nose, Throat · 94d
Cleared Dec 30, 1994
EMSEE LABS MODEL S
K944984 · ESD
Emsee Lab of Florida
Ear, Nose, Throat · 79d
Cleared Dec 30, 1994
EMSEE LABS MODE M
K944985 · ESD
Emsee Lab of Florida
Ear, Nose, Throat · 79d
Cleared Dec 30, 1994
EMSEE LABS MODEL C
K944986 · ESD
Emsee Lab of Florida
Ear, Nose, Throat · 79d
Cleared Dec 30, 1994
SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE
K945159 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 70d
Cleared Dec 29, 1994
ZINETICS AMC
K921682 · FFX
Zinetics Medical, Inc.
Gastroenterology & Urology · 995d
Cleared Dec 29, 1994
VANSONNENBERG GASTROSTOMY CATHETER
K924850 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 822d
Cleared Dec 29, 1994
REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION
K931595 · FIP
Osmonics, Inc.
Gastroenterology & Urology · 638d
Cleared Dec 29, 1994
EEG NEEDLE ELECTRODE
K933796 · GXZ
Cadwell Laboratories, Inc.
Neurology · 512d
Cleared Dec 29, 1994
EEG CUP ELECTRODE
K933808 · GXY
Cadwell Laboratories, Inc.
Neurology · 512d
Cleared Dec 29, 1994
CONCEPT UNIVERSAL PUMP SYSTEM
K933873 · HIG
Linvatec Corp.
Obstetrics & Gynecology · 507d
Cleared Dec 29, 1994
INNOVA VAGINAL EMG SENSING ELECTRODE
K940091 · HIR
Empi
Gastroenterology & Urology · 356d