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
118441–118464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1992
EXACTECH CERAMIC FEMORAL HEAD COMPONENT
K914574 · LZO
Exactech, Inc.
Orthopedic · 90d
Cleared Jan 13, 1992
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
K914676 · LZO
Zimmer, Inc.
Orthopedic · 87d
Cleared Jan 13, 1992
ASL MODEL #104
K914737 · ITI
Adaptive Switch Laboratories, Inc.
Physical Medicine · 84d
Cleared Jan 13, 1992
M170 PNEUMATICALLY OPERATED OSCILLATING SAW
K914845 · HSZ
Desutter Medical , Ltd.
Orthopedic · 77d
Cleared Jan 13, 1992
MICRO COMPUTER CONTROLS, MODEL# MCC-MK-RII-X
K914938 · ITI
Invacare Corp.
Physical Medicine · 70d
Cleared Jan 13, 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
K914946 · GKP
Helena Laboratories
Hematology · 76d
Cleared Jan 13, 1992
OPTI-LENS(TM) CONTACT LENS CASE
K915082 · LRX
Ryder Intl. Corp.
Ophthalmic · 62d
Cleared Jan 13, 1992
FOLDING WHEELCHAIR
K915108 · IOR
Guardian Products Co., Inc.
Physical Medicine · 61d
Cleared Jan 13, 1992
AUTO SUTURE MODIFIED POLYMER SKIN GRAFT STAPLE
K915151 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 60d
Cleared Jan 13, 1992
BANTEX BRAND WHEELCHAIRS
K915262 · IOR
Bantex Corp.
Physical Medicine · 55d
Cleared Jan 13, 1992
PEGASUS LATERAL CARDIAC POSITIONER
K915592 · JAA
Fischer Imaging Corp.
Radiology · 31d
Cleared Jan 13, 1992
B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT
K915671 · IOQ
Progressive Medical Technology, Inc.
Physical Medicine · 49d
Cleared Jan 13, 1992
BIODEX SYSTEM 2 AUTOPROGRAM
K915846 · IKK
Biodex Corp.
Physical Medicine · 31d
Cleared Jan 13, 1992
RIONET HEARING AID HB-71K (K-AMP)
K915875 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 10, 1992
MORSE ANESTHESIA
K905208 · FPA
North American Instrument Corp.
General Hospital · 416d
Cleared Jan 10, 1992
MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL
K912803 · FYA
Medical Sterilization, Inc.
General Hospital · 199d
Cleared Jan 10, 1992
CHEMO-PORT
K913386 · FMI
Hdc Corp.
General Hospital · 165d
Cleared Jan 10, 1992
TURNSOFT MATTRESS
K913933 · FNM
Turnsoft, Inc.
General Hospital · 129d
Cleared Jan 10, 1992
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
K914008 · FAJ
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 123d
Cleared Jan 10, 1992
PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P
K914106 · FGB
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 119d
Cleared Jan 10, 1992
UROVIEW 2000, MODIFICATION
K914446 · JAA
Oec-Diasonics, Inc.
Radiology · 98d
Cleared Jan 10, 1992
CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
K914523 · DSS
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 92d
Cleared Jan 10, 1992
STERILE SUGICAL GOWN PACK
K914563 · FYA
Assured Surgical Products, Inc.
General Hospital · 87d
Cleared Jan 10, 1992
LATEX PATIENT EXAMINATION GLOVES - HYPOALLERGENIC
K914709 · LYY
Klh Medical, Inc.
General Hospital · 84d