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
113857–113880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1993
BECTON DICKINSON ARTERIAL BLOOD GAS KITS
K930342 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 72d
Cleared Apr 07, 1993
HEARING AID (ALL-IN-THE-EAR)
K930542 · ESD
Action Labs, Inc.
Ear, Nose, Throat · 64d
Cleared Apr 07, 1993
MODIFIED ENDOSCOPIC CLAMP
K930567 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 70d
Cleared Apr 07, 1993
RIONET HEARING AID HB-53S
K930721 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 55d
Cleared Apr 07, 1993
DOMINATOR RADIOLOGY SYSTEM
K930997 · LMD
Dominator Radiology Systems, Inc.
Radiology · 65d
Cleared Apr 06, 1993
GISH ARTERIAL FILTER
K914791 · DTM
Gish Biomedical, Inc.
Cardiovascular · 531d
Cleared Apr 06, 1993
LUCOR CONFIRMATORY REAGENT
K922156 · GIR
Gradipore , Ltd.
Hematology · 334d
Cleared Apr 06, 1993
LUPO-TEST REGEANT
K922326 · GIR
Graoipore , Ltd.
Hematology · 330d
Cleared Apr 06, 1993
PERFECTA TOTAL HIP SYSTEM
K922847 · JDI
Orthomet, Inc.
Orthopedic · 295d
Cleared Apr 06, 1993
KENSEY NASH DYNAMIC CLIP SYSTEM
K923726 · GCJ
Kensey Nash Corp.
General & Plastic Surgery · 253d
Cleared Apr 06, 1993
PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT
K923983 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 242d
Cleared Apr 06, 1993
QUIKPAC STREP A TEST
K924007 · GTZ
Syntron Bioresearch, Inc.
Microbiology · 239d
Cleared Apr 06, 1993
BITE BLOCK
K924304 · JXL
United States Endoscopy Group, Inc.
Neurology · 223d
Cleared Apr 06, 1993
XENO MELANIN LENS
K924548 · HQY
Photoprotective Technologies
Ophthalmic · 209d
Cleared Apr 06, 1993
MEDI-SOL
K924571 · KOX
Orange-Sol, Inc.
General & Plastic Surgery · 208d
Cleared Apr 06, 1993
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
K924610 · BTM
Engineered Medical Systems
Anesthesiology · 207d
Cleared Apr 06, 1993
OPTEC 3000
K924741 · HKO
Stereo Optical Co., Inc.
Ophthalmic · 196d
Cleared Apr 06, 1993
THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES
K924938 · HQY
Eyeworks 3
Ophthalmic · 188d
Cleared Apr 06, 1993
OPERATIVE CHOLANGIOGRAM CATHETER
K924981 · GBZ
Taut, Inc.
General & Plastic Surgery · 187d
Cleared Apr 06, 1993
HORIZONTAL NEEDLE GUIDE ATTACHMENT
K925875 · GDF
Bip USA, Inc.
General & Plastic Surgery · 138d
Cleared Apr 06, 1993
IMMUNO RA UNDILUTED
K926569 · DHR
Immunostics Co., Inc.
Immunology · 96d
Cleared Apr 06, 1993
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
K926579 · HWC
Techmedica, Inc.
Orthopedic · 133d
Cleared Apr 06, 1993
SYNELISA JO-1 ANTIBODIES
K930281 · LLL
Elias U.S.A., Inc.
Immunology · 75d
Cleared Apr 06, 1993
SYNELISA SCL-70 ANTIBODIES
K930417 · LLL
Elias U.S.A., Inc.
Immunology · 70d