FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
42193–42216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2012
360 GAS ASSISTED ENDOSCOPIC APPLICATOR
K122526 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 88d
Cleared Nov 16, 2012
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
K122529 · HSX
Zimmer, Inc.
Orthopedic · 88d
Cleared Nov 16, 2012
ACCU-CHEK ULTRAFLEX INFUSION SET
K122686 · FPA
Roche Diabetes Care AG
General Hospital · 73d
Cleared Nov 16, 2012
ABL90 FLEX
K122729 · CHL
Radiometer Medical Aps
Chemistry · 71d
Cleared Nov 16, 2012
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING...
K123026 · LYY
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Nov 16, 2012
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
K123174 · LLZ
Ge Healthcare
Radiology · 37d
Cleared Nov 16, 2012
CD HORIZON SPIRE Z SPINAL SYSTEM
K123246 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 15, 2012
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
K113380 · GEI
Medtronic, Inc.
General & Plastic Surgery · 365d
Cleared Nov 15, 2012
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728 · MBP
Hans Biomed Corp.
Orthopedic · 332d
Cleared Nov 15, 2012
FEMMYCYCLE
K121857 · HHE
Femcap Incorporated
Obstetrics & Gynecology · 142d
Cleared Nov 15, 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
K122011 · OLO
Brainlab AG
Orthopedic · 129d
Cleared Nov 15, 2012
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
K122090 · MXC
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 122d
Cleared Nov 15, 2012
NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
K122886 · QSY
Hemostasis, LLC
General & Plastic Surgery · 56d
Cleared Nov 15, 2012
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K122899 · LJT
C.R. Bard, Inc.
General Hospital · 55d
Cleared Nov 15, 2012
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU
K122904 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 55d
Cleared Nov 15, 2012
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
K123259 · KNW
Devicor Medical Products, Inc.
Gastroenterology & Urology · 28d
Cleared Nov 14, 2012
KLS MARTIN RECON TALON
K122860 · HRS
KLS-Martin L.P.
Orthopedic · 57d
Cleared Nov 13, 2012
ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
K112830 · DSB
Noninvasive Medical Technologies, Inc.
Cardiovascular · 412d
Cleared Nov 13, 2012
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K120857 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 237d
Cleared Nov 13, 2012
HIGH FLOW INSUFFLANTION UNIT
K122180 · HIF
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 113d
Cleared Nov 13, 2012
VPAP S-A
K122324 · MNS
Resmed, Ltd.
Anesthesiology · 104d
Cleared Nov 13, 2012
VERTIFLEX DIRECT DECOMPRESSION SYSTEM
K122662 · HRX
Vertiflex, Inc.
Orthopedic · 74d
Cleared Nov 13, 2012
PASCAL LASER INDIRECT OPHTHALMOSCOPE
K123056 · HQF
Topcon Medical Laser Systems, Inc....
Ophthalmic · 43d
Cleared Nov 13, 2012
OPTIMA MR 430S
K123068 · LNH
Ge Medical Systems, LLC
Radiology · 43d