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
52873–52896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2009
MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM
K083004 · NKB
Aesculap Implant Systems, Inc.
Orthopedic · 267d
Cleared Jul 02, 2009
BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
K083686 · FMF
Anhui Kangda Medical Products Co., Ltd.
General Hospital · 202d
Cleared Jul 02, 2009
DESTINY MAX COAGULATION ANALYZER
K083896 · JPA
Trinity Biotech
Hematology · 185d
Cleared Jul 02, 2009
OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
K090522 · HRS
Osteomed LP
Orthopedic · 126d
Cleared Jul 02, 2009
ELECSYS PRECICONTROL UNIVERSAL
K090541 · JJY
Roche Diagnostics
Chemistry · 122d
Cleared Jul 02, 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554 · DQX
Boston Scientific Corp
Cardiovascular · 122d
Cleared Jul 02, 2009
CALCANEAL FRACTURE PLATE SYSTEM
K090582 · HRS
Tornier, Inc.
Orthopedic · 120d
Cleared Jul 02, 2009
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL...
K090851 · ODC
Byrne Medical, Inc.
Gastroenterology & Urology · 94d
Cleared Jul 02, 2009
MODIFICATION TO: NUVASIVE SPHERX SYSTEM
K090981 · NKB
Nuvasive, Inc.
Orthopedic · 86d
Cleared Jul 02, 2009
AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
K091007 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 84d
Cleared Jul 02, 2009
VORTEX CANNULA
K091304 · DWF
Vortex Medical, Inc.
Cardiovascular · 59d
Cleared Jul 02, 2009
BD FLU+ SYRINGE
K091377 · FMF
Becton, Dickinson & CO
General Hospital · 52d
Cleared Jul 02, 2009
MAMMOSITE II RADIATION THERAPY SYSTEM
K091378 · JAQ
Hologic, Inc.
Radiology · 52d
Cleared Jul 02, 2009
EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
K091596 · DRA
Evalve, Inc.
Cardiovascular · 30d
Cleared Jul 02, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K091627 · KCT
Smith & Nephew, Inc.
General Hospital · 29d
Cleared Jul 02, 2009
KOWA VX-10 A
K091683 · HKI
Kowa Co. , Ltd.
Ophthalmic · 22d
Cleared Jul 02, 2009
BIS CLICK SENSOR/CABLE
K091854 · GXY
Aspect Medical Systems, Inc.
Neurology · 13d
Cleared Jul 01, 2009
ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
K081923 · ONT
Glaxosmithkline Consumer Healthcare
General Hospital · 359d
Cleared Jul 01, 2009
S12X WITH ESAX OPTION
K082629 · GYC
Chatten Associates, Inc.
Neurology · 295d
Cleared Jul 01, 2009
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K083689 · FRN
B.Braun Medical, Inc.
General Hospital · 201d
Cleared Jul 01, 2009
INFLATABLE BONE TAMP
K090211 · NDN
Cardinal Health, Inc.
Orthopedic · 154d
Cleared Jul 01, 2009
REACTION SYSTEM
K090221 · NUV
Viora , Ltd.
General & Plastic Surgery · 152d
Cleared Jul 01, 2009
SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION...
K090336 · LZA
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 141d
Cleared Jul 01, 2009
POLARIS SPINAL SYSTEM
K090523 · NKB
Ebi, L.P.
Orthopedic · 125d