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
153985–154008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1984
PRESSURIZING/SCAVENGING ACRYLIC CEMENT
K840046 · KIH
Precision Medical Devices, Inc.
Orthopedic · 34d
Cleared Feb 09, 1984
PATELLA PROSTHESIS
K840100 · JWH
Techmedica, Inc.
Orthopedic · 30d
Cleared Feb 09, 1984
CARRIER
K840250 · LBE
Convaid Products, Inc.
Physical Medicine · 29d
Cleared Feb 09, 1984
BROOKER EXTERNAL FIXATION FRAME
K840286 · JDW
Depuy, Inc.
Orthopedic · 16d
Cleared Feb 08, 1984
CROUCH CORNEAL PROTECTOR
K833256 · HOY
Star Instrument Co.
Ophthalmic · 141d
Cleared Feb 08, 1984
PAO BIPOLAR COAGULATOR
K840545
Cimarron Instruments, Inc.
Obstetrics & Gynecology
Cleared Feb 07, 1984
MEDILAS LASER
K833557 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 123d
Cleared Feb 06, 1984
UV-A SUNTANNING EQUIPMENT 1000-8000
K834495 · FTC
Futuren, Inc.
General & Plastic Surgery · 80d
Cleared Feb 06, 1984
REDY 2000
K840743
Organon Teknika Corp.
Gastroenterology & Urology
Cleared Feb 04, 1984
HEMOFILTRATION SYSTEM
K831784 · KDI
Gambro, Inc.
Gastroenterology & Urology · 247d
Cleared Feb 04, 1984
FEEDING GASTROSTOMY TUBE
K832093 · KNT
Tri-Med, Inc.
Gastroenterology & Urology · 221d
Cleared Feb 04, 1984
MATTRESS COVER, ANTI-MICROBIAL
K832483 · FMW
American Threshold Industries, Inc.
General Hospital · 194d
Cleared Feb 04, 1984
SIMPLEX-2
K832541 · GQN
Gentech Australia
Immunology · 190d
Cleared Feb 04, 1984
UROMETER
K833043 · FFG
Browne Medical, Inc.
Gastroenterology & Urology · 151d
Cleared Feb 04, 1984
LAMINARIA JAPONICA CERVICAL DILATOR
K833068 · HDY
Medi-Spec
Obstetrics & Gynecology · 149d
Cleared Feb 04, 1984
RADIOIMMUNOASSAY, THYROID STIMU. HORMONE
K833193 · JLW
Biosan Laboratories, Inc.
Chemistry · 138d
Cleared Feb 04, 1984
SOUND IMAGER I
K833231 · IYO
Sound Imaging, Inc.
Radiology · 149d
Cleared Feb 04, 1984
NITROGLYCERINE CONTAINER
K833311 · NXB
Apothecary Products, Inc.
General Hospital · 131d
Cleared Feb 04, 1984
OCULASE 514 OPHTHALMIC ARGON LASER
K833532 · HQF
Lasermed Corp.
Ophthalmic · 116d
Cleared Feb 04, 1984
LAL TEST RELEASE & BONCHEK CAR/JACKET
K833555 · DTR
Shiley, Inc.
Cardiovascular · 110d
Cleared Feb 04, 1984
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · DYG
Instrumentation Laboratory CO
Cardiovascular · 81d
Cleared Feb 04, 1984
T3 RIA
K833853 · CDP
Syncor Intl. Corp.
Chemistry · 92d
Cleared Feb 04, 1984
C-LOOPS
K833856
Concept, Inc.
General & Plastic Surgery · 89d
Cleared Feb 04, 1984
SAV-A-LIMB
K833872 · KYR
Sil-Med Corp.
General Hospital · 88d