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
102025–102048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1995
TICARCILLIN/CLAVULANIC ACID 2
K951879 · JWY
Ab Biodisk
Microbiology · 84d
Cleared Jul 07, 1995
PRECISE DENTURE BASE RESIN
K952351 · EBI
Dentsply Intl.
Dental · 49d
Cleared Jul 07, 1995
POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER
K952428 · CAH
Porous Media Corp.
General Hospital · 44d
Cleared Jul 06, 1995
STERILE EQUIPMENT COVERS
K931417 · MMP
Custom Medical Products, Ltd.
General Hospital · 836d
Cleared Jul 06, 1995
F-230 POROUS FEMORAL HIP STEM (CEMENTLESS)
K941612 · LPH
Implex Corp.
Orthopedic · 458d
Cleared Jul 06, 1995
HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY
K943494 · LKF
Lyco Enterprises, Inc.
Obstetrics & Gynecology · 352d
Cleared Jul 06, 1995
FIXATION PINS/WIRES
K943856 · HTY
Acu Med, Inc.
Orthopedic · 332d
Cleared Jul 06, 1995
CLEAR ADVANTAGE II
K945628 · EXJ
Mentor Corp.
Gastroenterology & Urology · 232d
Cleared Jul 06, 1995
INTROPORT(TM) CATHETER MODEL #1000(ICT)
K946189 · LJT
Lifequest Medical, Inc.
General Hospital · 198d
Cleared Jul 06, 1995
PROFIX CONFORMING PLUS TIBIAL INSERT
K946236 · KWH
Smith & Nephew Richards, Inc.
Orthopedic · 196d
Cleared Jul 06, 1995
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE...
K946380 · HET
American Hydro-Surgical Instruments,...
Obstetrics & Gynecology · 205d
Cleared Jul 06, 1995
T-350 THERAPEUTIC COOLING MACHINE
K950711 · ILO
Thermotek, Inc.
Physical Medicine · 142d
Cleared Jul 06, 1995
3M MAXI-DRIVER II ELECTRIC SYSTEM
K951118 · GEY
3M Company
General & Plastic Surgery · 118d
Cleared Jul 06, 1995
THORACENTESIS CATHETER
K951524 · JOL
Baxter Healthcare Corp
General Hospital · 94d
Cleared Jul 06, 1995
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
K951673 · HSB
Acu Med, Inc.
Orthopedic · 86d
Cleared Jul 06, 1995
AMS 650 MALLERABLE PENIEL PROSTHESIS
K951716 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 06, 1995
GSI 65 COMPUTERIZED AUDIOMETER
K951759 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 80d
Cleared Jul 06, 1995
PIPER, MODEL NUMBER UDS-PIPERB
K951805 · FEN
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 79d
Cleared Jul 06, 1995
OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)
K951806 · LHQ
Opgal Optronic Industries
Radiology · 78d
Cleared Jul 06, 1995
MED-TEC REDI-FOAM
K951808 · IYE
Medtec, Inc.
Radiology · 78d
Cleared Jul 06, 1995
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC...
K952265 · IZO
Control-X, Inc.
Radiology · 52d
Cleared Jul 06, 1995
THE HILL ADJUSTABLE PODIATRY MODEL
K952357 · INQ
Hill Laboratories Co.
Physical Medicine · 70d
Cleared Jul 06, 1995
ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
K952408 · JOJ
Pymah Corp.
General Hospital · 45d
Cleared Jul 06, 1995
WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL
K952450 · ESD
Argosy Electronics
Ear, Nose, Throat · 42d