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
106849–106872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1994
KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC
K943821 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Aug 22, 1994
FUJI UM MAMMO SERIES INTENSIFY SCREENS:
K943822 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Aug 22, 1994
FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12
K943823 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Aug 19, 1994
MEDSURG INSERTION TRAY
K920780 · LFJ
Medsurg Industries, Inc.
Gastroenterology & Urology · 911d
Cleared Aug 19, 1994
THE RICHARDS WRIST
K931131 · JWJ
Smith & Nephew Richards, Inc.
Orthopedic · 532d
Cleared Aug 19, 1994
KS 5 - CLINICAL AUDIOMETER
K931322 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 521d
Cleared Aug 19, 1994
BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
K935045 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 302d
Cleared Aug 19, 1994
NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600
K935862 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 259d
Cleared Aug 19, 1994
SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
K936071 · HET
Smith & Nephew Dyonics, Inc.
Obstetrics & Gynecology · 242d
Cleared Aug 19, 1994
THEREX LOW-PROFILE PORT - TITANIUM MODEL
K942412 · LJT
Therex Corp.
General Hospital · 91d
Cleared Aug 19, 1994
ENTRAC URETERAL BALLOON DILATATION CATHETERS
K942578 · EZN
American Medical Systems, Inc.
Gastroenterology & Urology · 80d
Cleared Aug 19, 1994
GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT...
K942703 · GCJ
Gm Engineering, Inc.
General & Plastic Surgery · 72d
Cleared Aug 19, 1994
GAS SAMPLING INTERFACES
K943110 · BYX
Coast Medical, Inc.
Anesthesiology · 51d
Cleared Aug 19, 1994
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
K943229 · KDC
Y.M.K. International Co., Ltd.
General & Plastic Surgery · 44d
Cleared Aug 19, 1994
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293 · IOR
O'Tec Corp.
Physical Medicine · 42d
Cleared Aug 19, 1994
K.P.R. (KING PERSONAL RESUSCITATOR)
K943402 · CBP
King Systems Corp.
Anesthesiology · 36d
Cleared Aug 19, 1994
CAVI-CARE CONFORMING FOAM DRESSING
K943619 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 23d
Cleared Aug 18, 1994
BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
K910318 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 1302d
Cleared Aug 18, 1994
580CDR DISPLAY DRIVER
K934093 · DXJ
Vidco, Inc.
Cardiovascular · 360d
Cleared Aug 18, 1994
CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM
K935193 · LZO
U.S. Medical Products, Inc.
Orthopedic · 296d
Cleared Aug 18, 1994
C-SECTION TRAY
K940518 · MLS
Cush Medical Products
Obstetrics & Gynecology · 195d
Cleared Aug 18, 1994
FLEXGUIDE
K940799 · BSR
Scientific Sales Intl., Inc.
Anesthesiology · 177d
Cleared Aug 18, 1994
MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM
K940838 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 176d
Cleared Aug 18, 1994
CARDIOMETRICS DUALFLOW SWITCH BOX
K940984 · DQX
Cardio Metrics, Inc.
Cardiovascular · 170d