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
89425–89448 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1998
AMIGO RT
K981121 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 95d
Cleared Jun 30, 1998
LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES
K981172 · QPB
Byron Medical
General & Plastic Surgery · 90d
Cleared Jun 30, 1998
HIGH IMPEDANCE CARDIAC GATING CABLE
K981190 · LNH
GE Medical Systems
Radiology · 89d
Cleared Jun 30, 1998
FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT
K981194 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 89d
Cleared Jun 30, 1998
SYMPHONY 360 REMOTE CONTROL TABLE
K981227 · JAA
Acoma Medical Imaging, Inc.
Radiology · 88d
Cleared Jun 30, 1998
7200 ULTRASOUND IMAGING SYSTEM
K981293 · IYO
Biosound Esaote, Inc.
Radiology · 82d
Cleared Jun 30, 1998
HAMMERSMITH ENDOCAVITARY COILS
K981410 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 71d
Cleared Jun 30, 1998
TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM
K981714 · MNH
Acromed Corp.
Orthopedic · 46d
Cleared Jun 30, 1998
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717 · FTD
Stryker Instruments
General & Plastic Surgery · 46d
Cleared Jun 30, 1998
INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING
K981753 · MGP
Innovative Technologies , Ltd.
General & Plastic Surgery · 43d
Cleared Jun 29, 1998
RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
K965223 · IYO
Endosonics Corp.
Radiology · 545d
Cleared Jun 29, 1998
MODEL 7410 VOYAGER
K974879 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 181d
Cleared Jun 29, 1998
SURGITRON
K980170 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 160d
Cleared Jun 29, 1998
CHROMOSCAN SCANNING SYSTEM
K980753 · GEX
Mehl/Biophile Intl., Inc.
General & Plastic Surgery · 131d
Cleared Jun 29, 1998
GENIE CUP INTEGRATED SCREENING DEVICE
K980836 · LDJ
Applied Technology Ventures, LLC
Toxicology · 117d
Cleared Jun 29, 1998
ELECSYS CEA ON THE ELECSYS 1010
K980887 · DHX
Boehringer Mannheim Corp.
Immunology · 112d
Cleared Jun 29, 1998
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
K980915 · FYD
Valleylab, Inc.
General Hospital · 110d
Cleared Jun 29, 1998
LASETTE LASER SKIN PERFORATOR
K981149 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 90d
Cleared Jun 29, 1998
OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES
K981219 · GEI
Enable Medical Corp.
General & Plastic Surgery · 87d
Cleared Jun 29, 1998
BIOSTRIDE FREE T4 EIA TEST KIT
K981243 · CEC
Biostride Diagnostics, Inc.
Chemistry · 84d
Cleared Jun 29, 1998
VANTAGE 3.0 INSYNCH
K981291 · KPS
Adac Laboratories
Radiology · 81d
Cleared Jun 29, 1998
DAUM BONE BIOPSY SET
K981320 · KNW
Daum Corp.
Gastroenterology & Urology · 80d
Cleared Jun 29, 1998
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
K981342 · GKZ
Abbott Laboratories
Hematology · 77d
Cleared Jun 29, 1998
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR
K981362 · DZL
Synthes (Usa)
Dental · 75d