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
99001–99024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1996
ASLAN MODULAR INSTRUMENT
K954864 · GCJ
Aslan Medical Technologies, Ltd.
General & Plastic Surgery · 109d
Cleared Feb 09, 1996
HM-CAP EIA TEST (MODIFICATION)
K955085 · LYR
Schiff & Co.
Microbiology · 106d
Cleared Feb 09, 1996
PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY
K955157 · MHI
Alexon Biomedical, Inc.
Microbiology · 88d
Cleared Feb 09, 1996
SURGITRON
K955158 · HQR
Ellman Intl., Inc.
Ophthalmic · 88d
Cleared Feb 09, 1996
NEXFLEX FEMORAL STEM, STANDARD DESIGN
K955170 · LPH
Nexmed, Inc.
Orthopedic · 88d
Cleared Feb 09, 1996
NEXLOCK FEMORAL STEM
K955171 · JDG
Nexmed, Inc.
Orthopedic · 88d
Cleared Feb 09, 1996
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K955173 · KWP
Osteotech, Inc.
Orthopedic · 88d
Cleared Feb 09, 1996
VASCUTEK GELSOFT PLUS VASCULAR GRAFT
K955230 · DSY
Vascutek, Ltd.
Cardiovascular · 87d
Cleared Feb 09, 1996
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX
K955255 · JAK
Shimadzu Medical Systems
Radiology · 88d
Cleared Feb 09, 1996
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER...
K955396 · DTK
Boston Scientific Corp
Cardiovascular · 77d
Cleared Feb 09, 1996
QUEGEL HYDROPHILIC WOUND DRESSING
K955400 · MGQ
Questor Pharma, Inc.
General & Plastic Surgery · 77d
Cleared Feb 09, 1996
3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955427 · DZE
Implant Innovations, Inc.
Dental · 73d
Cleared Feb 09, 1996
BOZOTTA REINSERTION FORCEPS
K955480 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 71d
Cleared Feb 09, 1996
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K955569 · LCQ
Oxis Intl., Inc.
Toxicology · 65d
Cleared Feb 09, 1996
INNOFLUOR AMIKACIN ASSAY SYSTEM
K955570 · KLQ
Oxis Intl., Inc.
Toxicology · 65d
Cleared Feb 09, 1996
SYNCHRON SYSTEMS PROPOXYPHENE REAGENT
K955675 · JXN
Beckman Instruments, Inc.
Toxicology · 56d
Cleared Feb 09, 1996
RIGIDYNE A EXTERNAL FIXATION SYSTEM
K955780 · JDW
Zimmer, Inc.
Orthopedic · 50d
Cleared Feb 09, 1996
DIGITRACE HOME VIDEO SYSTEM
K955787 · OMB
New England Medical Instruments, Inc.
Neurology · 50d
Cleared Feb 09, 1996
CEDIA DAU LSD CALBIRATORS
K955813 · DLJ
Microgenics Corp.
Toxicology · 45d
Cleared Feb 09, 1996
CEDIA DAU LSD ASSAY
K955814 · DLB
Microgenics Corp.
Toxicology · 45d
Cleared Feb 09, 1996
PRO-TECH
K955850 · LRJ
Central Solutions, Inc.
General Hospital · 44d
Cleared Feb 09, 1996
BOEHRINGER MANNHEIM IGG ASSAY
K955906 · DFZ
Boehringer Mannheim Corp.
Immunology · 42d
Cleared Feb 09, 1996
BOEHRINGER MANNHEIM IGA ASSAY
K955907 · CZP
Boehringer Mannheim Corp.
Immunology · 42d
Cleared Feb 09, 1996
BOEHRINGER MANNHEIM IGM ASSAY
K955908 · DAO
Boehringer Mannheim Corp.
Immunology · 42d