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
69745–69768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2003
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
K031024 · BZH
Microlife Corp.
Anesthesiology · 228d
Cleared Nov 14, 2003
CLICK'X MONOAXIAL SCREWS AND HOOKS
K031175 · KWP
Synthes (Usa)
Orthopedic · 214d
Cleared Nov 14, 2003
AUTO-BAND LIGATOR
K031236 · MND
Scandimed. A.S.
Gastroenterology & Urology · 210d
Cleared Nov 14, 2003
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR,...
K031380 · LCP
Olympus America, Inc.
Chemistry · 197d
Cleared Nov 14, 2003
SPIROPRO SPO2
K031515 · DQA
Viasys Healthcare GmbH
Anesthesiology · 184d
Cleared Nov 14, 2003
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
K031646 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 170d
Cleared Nov 14, 2003
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · MHJ
Remel, Inc.
Microbiology · 141d
Cleared Nov 14, 2003
PASSMED SPINAL SYSTEM
K032094 · KWP
Medicrea
Orthopedic · 130d
Cleared Nov 14, 2003
BARD DUAL LUMEN URETERAL CATHETER
K032521 · EYB
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Nov 14, 2003
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
K032543 · EIA
Sirona Dental Systems GmbH
Dental · 88d
Cleared Nov 14, 2003
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV...
K032636 · HEB
Playtex Products, Inc.
Obstetrics & Gynecology · 79d
Cleared Nov 14, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR
K032670 · LYZ
Kingswell International, Inc.
General Hospital · 77d
Cleared Nov 14, 2003
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
K032777 · FOZ
Nipro Medical Corp.
General Hospital · 67d
Cleared Nov 14, 2003
PASCAL DYNAMIC CONTOUR TONOMETER
K032967 · HKY
Smt Swiss Microtechnology AG
Ophthalmic · 52d
Cleared Nov 14, 2003
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
K033007 · KXT
Bayer Diagnostics Corp.
Chemistry · 49d
Cleared Nov 14, 2003
MOBILETTE XP AND MOBILETT XPHYBRID
K033238 · IZL
Siemens Medical Systems, Inc.
Radiology · 39d
Cleared Nov 14, 2003
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
K033329 · HSB
Depuy, Inc.
Orthopedic · 29d
Cleared Nov 14, 2003
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
K033333 · FGE
Aomori Olympus Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Nov 14, 2003
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K033353 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Nov 14, 2003
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
K033358 · LIH
Surgitech, Inc.
Neurology · 25d
Cleared Nov 14, 2003
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
K033468 · DTM
Medtronic Perfusion Systems
Cardiovascular · 11d
Cleared Nov 13, 2003
COPC BAND
K021594 · MVA
Center For Orthotic and Prosthetic...
Neurology · 547d
Cleared Nov 13, 2003
POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS
K031170 · LYZ
Long First (Xiamen) Co., Ltd.
General Hospital · 213d
Cleared Nov 13, 2003
RAINBOW GT-4A PAIN RELIEF MACHINE
K031546 · GZJ
Sino-Us Information, Inc.
Neurology · 181d