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
121945–121968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1991
MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR
K901540 · GXD
Radionics, Inc.
Neurology · 371d
Cleared Apr 08, 1991
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM
K904420 · GEX
Fiber Delivery Concepts, Inc.
General & Plastic Surgery · 193d
Cleared Apr 08, 1991
CMS ONCOPROBE (TM)
K904421 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 193d
Cleared Apr 08, 1991
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
K904848 · HET
Origin Medsystems, Inc.
Obstetrics & Gynecology · 164d
Cleared Apr 08, 1991
PROBE SURGEON'S GLOVES- STERILE
K905624 · KGO
Glove India Pvt. , Ltd.
General Hospital · 115d
Cleared Apr 08, 1991
STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION
K905846 · LJT
Strato Medical Corp.
General Hospital · 102d
Cleared Apr 08, 1991
LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI
K905848 · LJT
Strato Medical Corp.
General Hospital · 102d
Cleared Apr 08, 1991
CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
K910020 · IZO
Capintec Instruments, Inc.
Radiology · 95d
Cleared Apr 08, 1991
SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65
K910051 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 91d
Cleared Apr 08, 1991
SCITECH BI-MANUAL ADAPTER CLIPS
K910088 · HQQ
Scitech Industries Partnership
Ophthalmic · 89d
Cleared Apr 08, 1991
3M LASER IMAGER XL
K910092 · LMC
3M Medical Products Group
Radiology · 89d
Cleared Apr 08, 1991
PLP LAPAROSCOPIC CHOLECYSTECTOMY SET
K910137 · GEX
Precision Laser Products, Inc.
General & Plastic Surgery · 89d
Cleared Apr 08, 1991
LAPAROMED CHOLANGIOGRAM VACUUM DEVICE
K910218 · GCX
Laparomed Corp.
General Hospital · 81d
Cleared Apr 08, 1991
LAPAROMED CHOLANGIOGRAM DEVICE
K910219 · FGE
Laparomed Corp.
Gastroenterology & Urology · 81d
Cleared Apr 08, 1991
10 ADJUSTABLE BELT COIL
K910269 · LNH
Resonex, Inc.
Radiology · 76d
Cleared Apr 08, 1991
TRACHEOSTOMY CARE KIT
K910362 · JOH
Megadyne Medical Products, Inc.
Anesthesiology · 69d
Cleared Apr 08, 1991
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
K910428 · FRN
Baxter Healthcare Corp
General Hospital · 67d
Cleared Apr 08, 1991
OSTEONICS(R) MID-SHAFT CEMENT SPACER
K910461 · JDK
Osteonics Corp.
Orthopedic · 63d
Cleared Apr 08, 1991
SYNCHRON LACTATE REAGENT
K910534 · KHP
Beckman Instruments, Inc.
Chemistry · 59d
Cleared Apr 08, 1991
ENZYMUN-TEST PROGESTERONE
K910683 · JLS
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Apr 08, 1991
EQUIPMENT/MATERIAL DECONTAMINATING KIT
K911299 · KIE
Rohm and Haas Co.
Toxicology · 14d
Cleared Apr 05, 1991
PROBET (TM)
K903002 · HFF
Gynopharma, Inc.
Obstetrics & Gynecology · 270d
Cleared Apr 05, 1991
NA ALPHA 1 MICROGLOBULIN KIT
K904254 · JZG
Behring Diagnostics, Inc.
Immunology · 203d
Cleared Apr 05, 1991
SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM
K905459 · LRO
Angiosystems, Inc.
General & Plastic Surgery · 121d