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
111745–111768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1993
CLOSED END FIBEROPTIC LASER DELIVERY SYSTEM
K931070 · GEX
Lca, Inc.
General & Plastic Surgery · 217d
Cleared Oct 05, 1993
JARIT SURGICAL INSTRUMENTS
K931959 · GEI
J. Jamner Surgical Instruments, Inc.
General & Plastic Surgery · 167d
Cleared Oct 05, 1993
NEW ENGLAND MEDICAL GROUNDING PAD
K931982 · GEI
New England Medical, Inc.
General & Plastic Surgery · 166d
Cleared Oct 05, 1993
VILA-COOKE(TM) ANESTHESIA PILLOW
K932305 · CCX
Sharn, Inc.
Anesthesiology · 146d
Cleared Oct 05, 1993
IMPLANTOLOGY MODULE, MODEL 2175
K932492 · JEY
Micro Surgical Instruments Corp.
Dental · 134d
Cleared Oct 05, 1993
CANDELA MINIBRUSH
K932930 · FEB
Candela Laser Corp.
General Hospital · 112d
Cleared Oct 05, 1993
DIGITAL IMAGE COMMUNICATIONS SYSTEM
K933103 · LMD
Analogic Corp.
Radiology · 103d
Cleared Oct 05, 1993
IMC 5.0MM IRRIGATION/ASPIRATION PROBE
K933305 · GCY
Inman Medical Corp.
General & Plastic Surgery · 90d
Cleared Oct 05, 1993
IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES
K933306 · GCY
Inman Medical Corp.
General & Plastic Surgery · 90d
Cleared Oct 05, 1993
ORTHOTRAC COAXIAL LASER
K933431 · OXO
Trac Medical, Inc.
Radiology · 83d
Cleared Oct 05, 1993
DISTENTION INSTRUMENT, MODIFICATION
K934134 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 48d
Cleared Oct 04, 1993
STERRAD CHEMICAL INDICATOR
K921910 · JOJ
Johnson & Johnson Medical, Inc.
General Hospital · 529d
Cleared Oct 04, 1993
FIXEL EXTERNAL FIXATION DEVICE
K923032 · KTT
Amp, Inc.
Orthopedic · 468d
Cleared Oct 04, 1993
PLASTIC LOW PROFILE SUBCUTANEOUS PORT
K924250 · LJT
Bard Access Systems, Inc.
General Hospital · 406d
Cleared Oct 04, 1993
POLY-MED DISPOSABLE PERSONAL PROTECTION KIT
K930026 · FYC
Medtek Development Corp.
General Hospital · 272d
Cleared Oct 04, 1993
P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR
K930712 · LZO
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 235d
Cleared Oct 04, 1993
OXY-BLOC
K931044 · MNK
Gi Supply
Gastroenterology & Urology · 217d
Cleared Oct 04, 1993
IL TEST (TM) PT-FIBRINOGEN HS PLUS
K933252 · GJS
Instrumentation Laboratory CO
Hematology · 94d
Cleared Oct 04, 1993
SPECTACLE FRAMES
K934033 · HQZ
H.M.O. Optical, Inc.
Ophthalmic · 47d
Cleared Oct 04, 1993
OPTIKOS SHAMI, INC. SPECTACLE FRAMES
K934198 · HQZ
Optikos Shami, Inc.
Ophthalmic · 39d
Cleared Oct 01, 1993
CAP WASHER ASSEMBLY
K915599 · KTT
Howmedica Corp.
Orthopedic · 658d
Cleared Oct 01, 1993
STERRAD 100 STERILIZATION SYSTEM
K915682 · FLF
Johnson & Johnson Medical, Inc.
General Hospital · 652d
Cleared Oct 01, 1993
STERRAD BI TEST PACK
K921909 · FRC
Johnson & Johnson Medical, Inc.
General Hospital · 526d
Cleared Oct 01, 1993
ALIBI OPTICAL FRAMES AND SUNGLASSES
K925187 · HQY
Alibi Designs, Inc.
Ophthalmic · 352d