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
168385–168408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1979
RED CAP, M-502
K791851 · BYX
Mem Medical, Inc.
Anesthesiology · 12d
Cleared Oct 01, 1979
T-PC FOR R.F. M.D., M-501
K791852
Mem Medical, Inc.
Cardiovascular · 12d
Cleared Oct 01, 1979
TEE- TWO-WAY VALVES M-500
K791853
Mem Medical, Inc.
Cardiovascular · 12d
Cleared Oct 01, 1979
CENTRIA HPL RIA
K791854 · JMF
Union Carbide Corp.
Chemistry · 12d
Cleared Oct 01, 1979
GLUCOSE OXIDASE (FRINDER) KIT
K791869 · CGA
Mid Tech, Inc.
Chemistry · 11d
Cleared Sep 28, 1979
PULSE GENERATORS, MODELS 5983, 5989
K790068 · DXY
Medtronic Vascular
Cardiovascular · 259d
Cleared Sep 28, 1979
HEARING AID, MODEL MA-1
K791142 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 102d
Cleared Sep 28, 1979
MITER ENDOSTEAL BLADE IMPLANT
K791204 · NRQ
Depuy, Inc.
Dental · 92d
Cleared Sep 28, 1979
DAHLBERG HEARING AID MODEL GC
K791310 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 74d
Cleared Sep 28, 1979
TA-10 PORTABLE SCREENING AUDIOMETER
K791467 · EWO
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 53d
Cleared Sep 28, 1979
REXTON HS(HEARING SYSTEM)
K791548 · HSD
Argosy Intl. (Usa), Inc.
Orthopedic · 46d
Cleared Sep 28, 1979
MODEL 33DA HEARING AIDS
K791599 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 28, 1979
MODEL 33A HEARING AIDS
K791600 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 28, 1979
MODEL 336A HEARING AIDS
K791601 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 28, 1979
CORDIS BIPOLAR PACER CONNECTOR SYSTEM
K791784 · DXY
Cordis Corp.
Cardiovascular · 16d
Cleared Sep 28, 1979
SUGITA ANEURYSM CLIPS, APPLIERS & CASE
K791978
Codman & Shurtleff, Inc.
Neurology
Cleared Sep 27, 1979
SPREADER
K781445 · GAD
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 400d
Cleared Sep 27, 1979
AUTO PAK VITAMIN B-12
K790347 · CDD
Micromedic Systems
Chemistry · 218d
Cleared Sep 27, 1979
PTH RIA 200
K791128 · CEW
Institut National Des Radioelements
Chemistry · 101d
Cleared Sep 27, 1979
DIAGNOSTIC ULTRASOUND SYSTEM
K791298 · IYO
Xonics Medical Systems, Inc.
Radiology · 73d
Cleared Sep 27, 1979
FAST FLOW #60310
K791365 · LCP
Hi Chem, Inc.
Hematology · 64d
Cleared Sep 27, 1979
TECHNICON STAR SYSTEM
K791549 · DON
Technicon Instruments Corp.
Toxicology · 45d
Cleared Sep 27, 1979
CAMPYLOBACTER SELECTIVE MEDIUM
K791578 · JSJ
Anaerobe Systems
Microbiology · 41d
Cleared Sep 27, 1979
VENTRE/SEP T3 TEST SET
K791588 · CDP
Ventrex Laboratories, Inc.
Chemistry · 41d