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
72265–72288 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2003
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K031028 · JEY
Bioplate, Inc.
Dental · 27d
Cleared Apr 28, 2003
ORTHOPEDIC WIRE
K031127 · JDR
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Apr 25, 2003
APNEACHECK
K022294 · MNR
Im Systems
Anesthesiology · 283d
Cleared Apr 25, 2003
TRAVELSOME STANDARD
K030233 · CAW
Sim Italia S.R.L.
Anesthesiology · 92d
Cleared Apr 25, 2003
FLAT PANEL DISPLAY, ME183L
K030272 · LLZ
Totoku Electric Co., Ltd.
Radiology · 88d
Cleared Apr 25, 2003
MEDICAL FLAT PANEL DISPLAY, ME315L
K030274 · LLZ
Totoku Electric Co., Ltd.
Radiology · 88d
Cleared Apr 25, 2003
FLAT PANEL DISPLAYS, CDL SERIES
K030276 · LLZ
Totoku Electric Co., Ltd.
Radiology · 88d
Cleared Apr 25, 2003
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
K030353 · OKS
Eagle Vision, Inc.
Ophthalmic · 81d
Cleared Apr 25, 2003
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60,...
K030959 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 29d
Cleared Apr 25, 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Apr 25, 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
K030975 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Apr 25, 2003
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR...
K030983 · MSD
Deltec, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 24, 2003
ELOX P 45-BP
K023205 · DTB
Biotronik, Inc.
Cardiovascular · 211d
Cleared Apr 24, 2003
APPLANATION TONOMETER
K023676 · HKX
Optilasa, S.L.
Ophthalmic · 174d
Cleared Apr 24, 2003
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
K030259 · KWS
Centerplus Orthopedics, Inc.
Orthopedic · 90d
Cleared Apr 24, 2003
BATTERY, RECHARGEABLE
K030261 · HGM
Access Battery, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 24, 2003
IMPACT SUTURE ANCHOR. MODEL 433510
K030388 · HWC
Bionx Implants, Ltd.
Orthopedic · 78d
Cleared Apr 24, 2003
C. DIFFICILE TOX A/B II
K030404 · LLH
Techlab, Inc.
Microbiology · 77d
Cleared Apr 24, 2003
A127 LEAD EXTENSION
K030461 · GZB
Advanced Neuromodulation Systems
Neurology · 71d
Cleared Apr 24, 2003
HL888JF
K030541 · DXN
Health & Life Co., Ltd.
Cardiovascular · 63d
Cleared Apr 24, 2003
RADII
K030568 · EBZ
Southern Dental Industries, Inc.
Dental · 59d
Cleared Apr 24, 2003
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
K030595 · KWQ
Blackstone Medical, Inc.
Orthopedic · 58d
Cleared Apr 24, 2003
QUANTA PLEX ENA PROFILE 5
K030681 · LLL
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Apr 24, 2003
SAFFRON NM GUIDING CATHETER
K030715 · DQY
Neich Medical (Shenzhen) Company Limited
Cardiovascular · 48d