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
72601–72624 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2003
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
K030768 · JJT
Cliniqa Corporation
Chemistry · 10d
Cleared Mar 21, 2003
STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH...
K030853 · FRG
Case Medical, Inc.
General Hospital · 3d
Cleared Mar 20, 2003
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1...
K022947 · DTQ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 196d
Cleared Mar 20, 2003
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
K023162 · FIE
Fresenius Medical Care
Gastroenterology & Urology · 178d
Cleared Mar 20, 2003
VISTA BASIC WITH FM SYSTEM
K023189 · FRN
B.Braun Medical, Inc.
General Hospital · 177d
Cleared Mar 20, 2003
STRYKER BIOZIP SUTURE ANCHOR
K023192 · HWC
Stryker Endoscopy
Orthopedic · 176d
Cleared Mar 20, 2003
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
K023487 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 154d
Cleared Mar 20, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
K023692 · LWJ
Howmedica Osteonics Corp.
Orthopedic · 136d
Cleared Mar 20, 2003
CRYOPROBE
K024009 · GEH
H&O Equipments, Nv/Sa
General & Plastic Surgery · 106d
Cleared Mar 20, 2003
OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
K024012 · JAA
Ge Oec Medical Systems
Radiology · 106d
Cleared Mar 20, 2003
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
K024291 · HRX
Arthrex, Inc.
Orthopedic · 86d
Cleared Mar 20, 2003
ENHANCE SPERM FREEZE
K030117 · MQL
Conception Technology, Inc.
Obstetrics & Gynecology · 66d
Cleared Mar 20, 2003
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6,...
K030149 · FPA
Avail Medical Products, Inc.
General Hospital · 64d
Cleared Mar 20, 2003
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
K030200 · LYZ
Kaohsiung Brothers Products Corp.
General Hospital · 58d
Cleared Mar 20, 2003
GENICON CLIP APPLIER
K030269 · FZP
Genicon, LC
General & Plastic Surgery · 52d
Cleared Mar 20, 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368 · HWC
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 44d
Cleared Mar 20, 2003
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K030378 · GXN
Stryker Instruments
Neurology · 43d
Cleared Mar 20, 2003
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
K030411 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 41d
Cleared Mar 20, 2003
ORIA ZENITH
K030500 · KWQ
Ortho Tec, LLC
Orthopedic · 29d
Cleared Mar 20, 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Mar 20, 2003
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
K030537 · GZJ
Well-Life Healthcare, Inc.
Neurology · 28d
Cleared Mar 20, 2003
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
K030597 · HRS
Synthes (Usa)
Orthopedic · 23d
Cleared Mar 20, 2003
EVA DIGITAL DENTAL X-RAY SYSTEM
K030647 · EHD
Afp Imaging Corp.
Radiology · 20d
Cleared Mar 20, 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698 · JXG
Aesculap, Inc.
Neurology · 14d