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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68353–68376 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2004
HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
K040306 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 43d
Cleared Mar 23, 2004
GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE,...
K040448 · LYY
Rosner-Mautby Meditrade(Thailand) , Ltd.
General Hospital · 32d
Cleared Mar 23, 2004
TRIGEN TROCHANTERIC ANTEGRADE NAIL
K040462 · HSB
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Mar 23, 2004
TERUMO SURGUARD2 SAFETY NEEDLE
K040531 · FMI
Terumo Medical Corp.
General Hospital · 22d
Cleared Mar 23, 2004
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)
K040532 · LYZ
Zi BO Hong Wang Plastic & Rubber...
General Hospital · 22d
Cleared Mar 23, 2004
ROBERTSITE VIAL ADAPTER, MODEL 245700021
K040634 · LHI
Halkey-Roberts Corp.
General Hospital · 13d
Cleared Mar 23, 2004
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
K040691 · EIA
Win-Us Technology Co., Ltd.
Dental · 6d
Cleared Mar 22, 2004
MODEL AVANT 2120 PULSE OXIMETER AND NIBP
K031487 · DXN
Nonin Medical, Inc.
Cardiovascular · 315d
Cleared Mar 22, 2004
BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
K032292 · FOZ
Bioteque Corp.
General Hospital · 242d
Cleared Mar 22, 2004
NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
K033000 · BYJ
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 179d
Cleared Mar 22, 2004
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
K033454 · JZO
Brahms Diagnostica, LLC
Immunology · 144d
Cleared Mar 22, 2004
INFINITY MODULAR MONITORS VF4 MODIFICATIONS
K033694 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 119d
Cleared Mar 22, 2004
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K033977 · JZO
Zeus Scientific, Inc.
Immunology · 90d
Cleared Mar 22, 2004
CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B
K034050 · DTK
Cordis Corporation
Cardiovascular · 83d
Cleared Mar 22, 2004
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1
K040002 · DXN
Microlife Intellectual Property Gmb
Cardiovascular · 80d
Cleared Mar 22, 2004
APM BLOOD PRESSURE MONITOR, MODEL BP108A
K040159 · DXN
Asia Pacific Microsystems, Inc.
Cardiovascular · 59d
Cleared Mar 22, 2004
ZYOPTIX XP MICROKERATOME
K040204 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Mar 22, 2004
INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS
K040205 · NHA
Intra-Lock International
Dental · 52d
Cleared Mar 22, 2004
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
K040541 · JAQ
Varian Medical Systems, Inc.
Radiology · 20d
Cleared Mar 22, 2004
SOMATOM PROJECT P30L
K040577 · JAK
Siemens Medical Systems, Inc.
Radiology · 18d
Cleared Mar 22, 2004
MESACUP TEST MPO, MODEL 11053
K040586 · MOB
Rhigene, Inc.
Immunology · 17d
Cleared Mar 22, 2004
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
K040640 · MOS
Igc-Medical Advances, Inc.
Radiology · 12d
Cleared Mar 19, 2004
ACCULASER PRO4
K023060 · NHN
Acculaser, Inc.
Physical Medicine · 553d
Cleared Mar 19, 2004
SOLAR GI SYSTEM
K031084 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 350d