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
164113–164136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1981
ELECTROENCEPHALOMYOGRAPH
K810359 · OLT
Thoracel Research Labs.
Neurology · 31d
Cleared Mar 13, 1981
CORRUGATED FLEX TUBING #6000,
K810374 · BYX
Todd Industries, Inc.
Anesthesiology · 29d
Cleared Mar 13, 1981
THINLITH II PULSE GNEERATOR MODEL 227-05
K810386 · DXY
Intermedics, Inc.
Cardiovascular · 28d
Cleared Mar 13, 1981
VICRYL
K810428 · FTL
Ethicon, Inc.
General & Plastic Surgery · 23d
Cleared Mar 13, 1981
VENTURI MASK/DELIVERY SYSTEM #6078
K810430 · BYF
Todd Industries, Inc.
Anesthesiology · 22d
Cleared Mar 13, 1981
CORDIS PERVENOUS ATRIAL LEAD
K810432 · DTB
Cordis Corp.
Cardiovascular · 22d
Cleared Mar 13, 1981
LOWER EXTREMITY SUPPORT SYSTEM-LESS
K810433 · FWZ
Walgen Medical Innoventions
General & Plastic Surgery · 22d
Cleared Mar 13, 1981
SCANLAN SUTURE BOOTS
K810480 · KOC
Scanlan Intl., Inc.
Hematology · 18d
Cleared Mar 13, 1981
GOMCO SUCTION PUMP CABINET CHANGE
K810490 · BTA
Allied Healthcare Products, Inc.
General & Plastic Surgery · 17d
Cleared Mar 13, 1981
VERI/PMS MODEL 815
K810496 · IPF
Verite
Physical Medicine · 17d
Cleared Mar 13, 1981
MEDISEAL CAMERA COVERS
K810512 · KQM
Janin Group, Inc.
General & Plastic Surgery · 17d
Cleared Mar 13, 1981
MOURADIAN MODIFIED ZICKEL HUMERAL ROD
K810535 · HSB
Howmedica Corp.
Orthopedic · 15d
Cleared Mar 13, 1981
CEMENT FUME EVACUATOR TANK & FILTER
K810542 · JDY
Walgen Medical Innoventions
Orthopedic · 14d
Cleared Mar 13, 1981
LUMBAR FLEXION BRACE
K810554 · IPY
Orthomedics
Physical Medicine · 11d
Cleared Mar 13, 1981
SCOLIOSIS ORTHOTIC SYSTEM
K810555 · IQF
Orthomedics
Physical Medicine · 11d
Cleared Mar 13, 1981
SPINAL EXTENSION BRACE
K810556 · IPY
Orthomedics
Physical Medicine · 11d
Cleared Mar 13, 1981
HIP ABDUCTION SPLINT
K810557 · IOZ
Orthomedics
Physical Medicine · 11d
Cleared Mar 13, 1981
GERMCO TEST R GLUCOSE TEST KIT
K810567 · CGA
Fermco Biochemics, Inc.
Chemistry · 10d
Cleared Mar 13, 1981
BECKMAN THEOPHYLLINE REAGENT TEST KIT
K810578 · KLS
Beckman Instruments, Inc.
Toxicology · 10d
Cleared Mar 13, 1981
ELECTRODE, PACEMAKER PERMANENT
K810582 · DTB
Pacesetter Systems
Cardiovascular · 10d
Cleared Mar 13, 1981
NEUROPAC ULTRA I
K810593 · GZJ
Medical Devices, Inc.
Neurology · 8d
Cleared Mar 13, 1981
CURITY 100% SILICONE IRRIGATION FOLEY
K810691 · EZL
The Kendal Co.
Gastroenterology & Urology
Cleared Mar 12, 1981
SILICONE ELBOW, BED AND CHAIR PADS
K810440 · KIC
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Mar 11, 1981
SERIES 4000 STRESS & EXERCISE SYSTEM
K801903 · DSI
Instruments For Cardiac Research
Cardiovascular · 212d