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
127969–127992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 1989
CONDOM (RUBBER LATEX) OKEIDO
K894534 · HIS
Rfsu
Obstetrics & Gynecology · 148d
Cleared Dec 14, 1989
RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT
K894643 · IZL
Lorad Medical Systems, Inc.
Radiology · 143d
Cleared Dec 14, 1989
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF
K894887 · JAK
Shimadzu Medical Systems
Radiology · 135d
Cleared Dec 14, 1989
BIRDS'N BEES CONDOMS
K895028 · HIS
Rfsu
Obstetrics & Gynecology · 128d
Cleared Dec 14, 1989
KIM MODULAR FEMORAL HIP PROSTHESIS
K895399 · LZO
Dow Corning Wright
Orthopedic · 98d
Cleared Dec 14, 1989
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)
K895408 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 99d
Cleared Dec 14, 1989
THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL
K895442 · KPQ
Altek Corp.
Radiology · 97d
Cleared Dec 14, 1989
CIVCO LATEX ULTRASOUND SHEATHS
K895614 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 86d
Cleared Dec 14, 1989
DIMENSION REVISION TOTAL HIP SYSTEM
K895636 · JDI
Kirschner Medical Corp.
Orthopedic · 86d
Cleared Dec 14, 1989
MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR
K895837 · GEX
Medical Laser, Inc.
General & Plastic Surgery · 72d
Cleared Dec 14, 1989
GYROSCAN T5 MOBILE
K895869 · LNH
Philips Medical Systems, Inc.
Radiology · 71d
Cleared Dec 14, 1989
PROFIL CONDOM (RUBBER LATEX)
K895894 · HIS
Rfsu
Obstetrics & Gynecology · 70d
Cleared Dec 14, 1989
HYSTEROFLATOR 2001
K895907 · HIG
Cabot Medical Corp.
Obstetrics & Gynecology · 69d
Cleared Dec 14, 1989
STERILE DISPOSABLE INFRATIP
K895918 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 65d
Cleared Dec 14, 1989
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR)
K896050 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 57d
Cleared Dec 14, 1989
RADIATION PROTECTION APRON
K896289 · KPY
Infab Corp.
Radiology · 44d
Cleared Dec 14, 1989
KEY VASCULAR BOOTIES
K896472 · MAW
Key Surgical, Inc.
General & Plastic Surgery · 31d
Cleared Dec 14, 1989
JAW BLOCKER
K896745 · JXL
Plastic Engineered Products Co.
Neurology · 14d
Cleared Dec 13, 1989
VERIMED MYOEXORCISER III (MYO III)
K892649 · HCC
Verimed Holdings, Inc.
Neurology · 245d
Cleared Dec 13, 1989
HAEMOPHILUS TEST MEDIUM (HTM)AGAR
K894216 · JSO
Bd Becton Dickinson Vacutainer...
Microbiology · 177d
Cleared Dec 13, 1989
DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.
K894356 · LDD
Phycon
Cardiovascular · 152d
Cleared Dec 13, 1989
TEST ONE
K894662 · IKK
Primed Products, Inc.
Physical Medicine · 142d
Cleared Dec 13, 1989
MT96000 PAPER CHART RECORDER
K894736 · DSF
Astro-Med, Inc.
Cardiovascular · 139d
Cleared Dec 13, 1989
AMCATH URETERAL DILATORS MODELS 7100,7110,7120
K894925 · EZN
Intec Medical, Inc.
Gastroenterology & Urology · 133d