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
102625–102648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1995
ATT-300
K944699 · ITH
Health Care Mfg., Inc.
Physical Medicine · 245d
Cleared May 26, 1995
OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
K945262 · FAJ
Optus, Inc.
Gastroenterology & Urology · 210d
Cleared May 26, 1995
GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE
K950311 · GDF
Global Medical Products, Ltd.
General & Plastic Surgery · 130d
Cleared May 26, 1995
ALEXLAZR
K950831 · GEX
Candela Laser Corp.
General & Plastic Surgery · 91d
Cleared May 26, 1995
RECONSTITUTION ACCESSOREIS
K950861 · FPK
Organon, Inc.
General Hospital · 88d
Cleared May 26, 1995
AOI UNIVERSAL ULTRASONIC HANDPIECE
K950880 · HQC
American Optical Corp.
Ophthalmic · 88d
Cleared May 26, 1995
MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS
K951324 · KCZ
Maxol Limited L.C.
General & Plastic Surgery · 64d
Cleared May 26, 1995
UROTEK RE-USABLE FIBEROPTIC CABLE
K951933 · GEX
Energy Life Systems Corp.
General & Plastic Surgery · 31d
Cleared May 26, 1995
MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS)
K952300 · GET
Midas Rex Pneumatic Tools, Inc.
General & Plastic Surgery · 10d
Cleared May 25, 1995
GERBER NATURAL COMFORT BATTERY BREAST PUMP
K942534 · HGX
Gerber Products Co.
Obstetrics & Gynecology · 363d
Cleared May 25, 1995
ARTHROSCOPIC TELESCOPES
K943052 · HRX
Karl Storz Endoscopy
Orthopedic · 332d
Cleared May 25, 1995
LAPARASCOPE
K943662 · HET
Pollux Endoscopy, Inc.
Obstetrics & Gynecology · 301d
Cleared May 25, 1995
TEEN 100
K945213 · BZC
Aerosport, Inc.
Anesthesiology · 212d
Cleared May 25, 1995
MCA(TM) 180 HEMODIALYZER
K945622 · FJI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 191d
Cleared May 25, 1995
OREX(R) O.R EQUIPMENT DRAPES
K945755 · KKX
Thantex Specialties, Inc.
General Hospital · 183d
Cleared May 25, 1995
DEPUY CDH PROSTHESIS
K945844 · MEH
Depuy, Inc.
Orthopedic · 176d
Cleared May 25, 1995
KSE STEINER ELECTROMECHANIC MORCELLATOR
K946147 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 160d
Cleared May 25, 1995
3M FILTRETE(TM) AIR FILTER MEDIA
K946225 · CBP
Tagg Industries
Anesthesiology · 164d
Cleared May 25, 1995
CR PERFECT
K950142 · CGX
Chimera Research & Chemical, Inc.
Chemistry · 132d
Cleared May 25, 1995
METAL BACKED ACETABULAR COMPONENT
K950542 · JDL
Encore Orthopedics, Inc.
Orthopedic · 107d
Cleared May 25, 1995
LAPAROSCOPIC CLAMP
K950702 · GCJ
Applied Medical Resources
General & Plastic Surgery · 99d
Cleared May 25, 1995
LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000
K950708 · KXO
Graphic Controls Corp.
Obstetrics & Gynecology · 101d
Cleared May 25, 1995
LOWE KLEARWAY
K950763 · LRK
Dr. Alan A. Lowe, Inc.
Dental · 97d
Cleared May 25, 1995
QUEST ANTEGRADE CARDIOPLEGIA CANNULA
K950814 · DWF
Quest Medical, Inc.
Cardiovascular · 92d