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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79417–79440 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2001
MODIFICATION TO EDI VERIS SYSTEM
K003442 · HLX
Electro-Diagnostic Imaging, Inc.
Ophthalmic · 179d
Cleared May 04, 2001
DEVILBISS HUMIDIFIER
K003626 · BTT
Sunrise Medical Hhg, Inc.
Anesthesiology · 161d
Cleared May 04, 2001
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K003943 · KLK
Linde Medical Sensors AG
Anesthesiology · 134d
Cleared May 04, 2001
IVD (IN VIVO DOSIMETER), MODEL 1131
K010449 · IYE
Sun Nuclear Corp.
Radiology · 78d
Cleared May 04, 2001
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
K011050 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 28d
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared May 04, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER...
K011098 · MXC
Medtronic Vascular
Cardiovascular · 23d
Cleared May 04, 2001
APEX FIXATION PINS
K011136 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared May 04, 2001
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
K011178 · LQC
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 17d
Cleared May 04, 2001
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES...
K011224 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 14d
Cleared May 03, 2001
TISSUE MARKER
K001807 · GDW
Advanced Uroscience, Inc.
General & Plastic Surgery · 322d
Cleared May 03, 2001
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
K002256 · DSP
Arrow Intl., Inc.
Cardiovascular · 282d
Cleared May 03, 2001
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230...
K002565 · GXD
Baylis Medical Co., Inc.
Neurology · 259d
Cleared May 03, 2001
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
K003458 · HGP
Clinical Innovations, Inc.
Obstetrics & Gynecology · 177d
Cleared May 03, 2001
SANARUS CORE TISSUE BIOPSY SYSTEM
K003528 · KNW
Endocare, Inc.
Gastroenterology & Urology · 168d
Cleared May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344 · KTT
Synthes (Usa)
Orthopedic · 87d
Cleared May 03, 2001
TANTALUM BEADS - RADIOGRAPHIC MARKER
K010348 · NEU
Biomet, Inc.
General & Plastic Surgery · 87d
Cleared May 03, 2001
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE)...
K010483 · LYY
Pt. Medisafe Technologies
General Hospital · 72d
Cleared May 03, 2001
BIPOLAR PENCIL, MODEL 3901-002, 3900-002
K010487 · GEI
Medtronic PS Medical
General & Plastic Surgery · 72d
Cleared May 03, 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499 · JEY
Synthes (Usa)
Dental · 71d
Cleared May 03, 2001
NEUROPLUS, MODEL A10040, A10041, A10042, A10043
K010638 · GXY
Vermont Medical, Inc.
Neurology · 59d
Cleared May 03, 2001
MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
K010661 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 63d
Cleared May 03, 2001
KOALA CLAMP
K010695 · HFW
Maternus, Inc.
Obstetrics & Gynecology · 56d
Cleared May 03, 2001
LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF...
K010863 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 42d