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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133849–133872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1988
AREA (DENTAL CHAIR)
K880474 · KLC
Alpine Dental Equipment Co.
Dental · 232d
Cleared Sep 23, 1988
SKEMA (DENTAL UNIT)
K880475 · KLC
Alpine Dental Equipment Co.
Dental · 232d
Cleared Sep 23, 1988
IVY COMMANDER, MODEL 600
K882167 · LDR
Ivy Medical, Inc.
General Hospital · 122d
Cleared Sep 23, 1988
DUAL-TEMP(TM) COOLING/WARMING UNIT
K882310 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 112d
Cleared Sep 23, 1988
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
K882427 · DXY
Ela Medical, Inc.
Cardiovascular · 102d
Cleared Sep 23, 1988
COLTENE PRESIDENT JET REGULAR BODY
K882800 · ELW
Coltene, Inc.
Dental · 78d
Cleared Sep 23, 1988
CASF DRILL GUIDE DG 170
K882871 · LYQ
Terray Manufacturing, Inc.
Orthopedic · 74d
Cleared Sep 23, 1988
SAFESITE INJECTION SITE AND BLUNT CANNULA
K883638 · FPA
Baxter Healthcare Corp
General Hospital · 29d
Cleared Sep 23, 1988
STERILE EMPTY GLASS VIALS
K883686 · LDH
Farris Laboratories, Inc.
General Hospital · 25d
Cleared Sep 22, 1988
MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM
K875072 · GZJ
Amana Medical Group
Neurology · 288d
Cleared Sep 22, 1988
NOVA LITE(TM) SA
K881341 · LLL
Inova Diagnostics, Inc.
Immunology · 177d
Cleared Sep 22, 1988
GARDS DEODORANT SANITARY NAPKIN
K882094 · HHL
Hospital Specialty Co.
Obstetrics & Gynecology · 126d
Cleared Sep 22, 1988
SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)
K882231 · IYE
Philips Medical Systems, Inc.
Radiology · 118d
Cleared Sep 22, 1988
SPINAL MICROKNIFE
K882525 · HTS
Karlin Technology, Inc.
Orthopedic · 97d
Cleared Sep 22, 1988
EMPI MODEL 727,NMS
K882631 · GZJ
Empi
Neurology · 87d
Cleared Sep 22, 1988
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
K882678 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 86d
Cleared Sep 22, 1988
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
K882740 · LKJ
Lipogen, Inc.
Immunology · 83d
Cleared Sep 22, 1988
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
K882907 · JLW
Amersham Corp.
Chemistry · 72d
Cleared Sep 22, 1988
TECHMEDICA MP SYSTEM
K882922 · KTT
Techmedica, Inc.
Orthopedic · 71d
Cleared Sep 22, 1988
QM300 CALIBRATOR D PACK
K883001 · CZJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 66d
Cleared Sep 22, 1988
QM300 PREALBUMIN ANTIBODY PACK
K883002 · JZJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 66d
Cleared Sep 22, 1988
EPICARDIA PC/FC
K883103 · DSI
Medicomp, Inc.
Cardiovascular · 62d
Cleared Sep 22, 1988
HIP FRACTURE STEM SYSTEM
K883179 · KWL
Howmedica Corp.
Orthopedic · 57d
Cleared Sep 22, 1988
AVL MODEL 986 ELECTROLYTE ANALYZER
K883240 · CEM
Avl Scientific Corp.
Chemistry · 52d