Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
50713–50736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2010
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
K100676 · HRS
Synthes (Usa)
Orthopedic · 29d
Cleared Apr 08, 2010
SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
K100701 · NBW
Biotest Medical Corp.
Chemistry · 27d
Cleared Apr 07, 2010
APEX ARC HIP STEM
K090845 · LZO
Omni Life Science, Inc.
Orthopedic · 376d
Cleared Apr 07, 2010
PROVANT SYSTEM, MODEL 4201
K091791 · ILX
Regenesis Biomedical, Inc.
Physical Medicine · 294d
Cleared Apr 07, 2010
LANX ANTERIOR PLATING SYSTEM
K092765 · KWQ
Lanx, Inc.
Orthopedic · 210d
Cleared Apr 07, 2010
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
K092984 · LKF
Panpac Medical Corporation
Obstetrics & Gynecology · 191d
Cleared Apr 07, 2010
COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
K093243 · GJS
Coagusense, Inc.
Hematology · 174d
Cleared Apr 07, 2010
NAVIX ACCESS DEVICE
K093279 · GCJ
Xlumena
General & Plastic Surgery · 169d
Cleared Apr 07, 2010
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
K093441 · KXT
Siemens Healthcare Diagnostics
Chemistry · 153d
Cleared Apr 07, 2010
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
K093845 · GDW
Ethicon, Inc.
General & Plastic Surgery · 113d
Cleared Apr 07, 2010
ALPHA ORTHOPAEDICS AT3 SYSTEM
K094041 · GEI
Alpha Orthopaedics
General & Plastic Surgery · 98d
Cleared Apr 07, 2010
ARCHIMED REMEDY CERVICAL PLATE
K100215 · KWQ
Archimed, Inc.
Orthopedic · 72d
Cleared Apr 07, 2010
ESTECH COBRA BIPOLSR II
K100224 · GEI
Endoscopic Technologies, Inc. D/B/A...
General & Plastic Surgery · 71d
Cleared Apr 07, 2010
HARMONIC FOCUS SHEARS
K100597 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 36d
Cleared Apr 07, 2010
FEMVUE CORNUAL BALLOON CATHETER
K100662 · LKF
Femasys, Inc.
Obstetrics & Gynecology · 30d
Cleared Apr 06, 2010
VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR
K091770 · LYZ
Shijiazhuang Huijingyuan Plastic Co,...
General Hospital · 294d
Cleared Apr 06, 2010
MED-LOK
K093176 · MEG
Sta-Med, LLC
General Hospital · 180d
Cleared Apr 06, 2010
MERCURY MEDICAL T-PIECE RESUSCITATOR
K093913 · BTL
Mercury Medical, Inc.
Anesthesiology · 105d
Cleared Apr 06, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100419 · LYZ
Tangshan Yongkang Glove Co., Ltd.
General Hospital · 49d
Cleared Apr 06, 2010
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K100673 · JGS
Medica Corp.
Chemistry · 28d
Cleared Apr 06, 2010
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · IZH
Hologic, Inc.
Radiology · 27d
Cleared Apr 05, 2010
MINIHIP STEM
K083312 · LZO
Corin USA
Orthopedic · 511d
Cleared Apr 05, 2010
SYSTEM 1.5 STERILE PROCESSING SYSTEM
K090036 · MED
STERIS Corporation
General Hospital · 454d
Cleared Apr 05, 2010
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
K092387 · FEB
Minntech Corp.
General Hospital · 243d