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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37873–37896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2014
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
K133957 · BYE
Galemed Corp.
Anesthesiology · 112d
Cleared Apr 14, 2014
CABOCHON SYSTEM
K134010 · OUP
Cabochon Aesthetics, Inc.
General & Plastic Surgery · 105d
Cleared Apr 14, 2014
ELISIO-H HEMODIALYZER
K140191 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 77d
Cleared Apr 14, 2014
NAMIC RCS SYRINGE
K140194 · FMF
Navilyst Medical, Inc.
General Hospital · 77d
Cleared Apr 14, 2014
PICASSO II MIS SPINAL SYSTEM
K140219 · NKB
Accel Spine
Orthopedic · 75d
Cleared Apr 11, 2014
POWDERED VINYL EXAMINATION GLOVES
K122176 · LYZ
Shu Tong Xinghua Co., Ltd.
General Hospital · 627d
Cleared Apr 11, 2014
POWDER FREE VINYL EXAMINATION GLOVES
K122377 · LYZ
Shu Tong Xinghua Co., Ltd.
General Hospital · 627d
Cleared Apr 11, 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · KLE
Bisco, Inc.
Dental · 302d
Cleared Apr 11, 2014
AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
K131883 · MNR
Inovise Medical, Inc.
Anesthesiology · 290d
Cleared Apr 11, 2014
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD),...
K131906 · EBZ
Satelec - Acteon Group
Dental · 289d
Cleared Apr 11, 2014
RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
K132138 · PDQ
Rhythmlink International, LLC
Neurology · 274d
Cleared Apr 11, 2014
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
K132312 · LPH
Renovis Surgical Technologies, LLC
Orthopedic · 260d
Cleared Apr 11, 2014
AIR-FLOW HANDY 3.0
K132478 · EFB
E.M.S Electro Medical Systems S.A
Dental · 246d
Cleared Apr 11, 2014
PROPOSED OPTIMUS
K132596 · OVD
Custom Spine, Inc.
Orthopedic · 235d
Cleared Apr 11, 2014
SPINEWORKS ANTERIOR LUMBAR DEVICE
K133340 · MAX
Spineworks, LLC
Orthopedic · 163d
Cleared Apr 11, 2014
REVEEL ENDOSCOPIC RETRACTOR
K133345 · GCJ
Retraction Limited
General & Plastic Surgery · 163d
Cleared Apr 11, 2014
AZE PHOENIX SOFTWARE
K133521 · LLZ
Aze, Ltd.
Radiology · 147d
Cleared Apr 11, 2014
REVOLUTION CT
K133705 · JAK
Ge Medical Systems, LLC
Radiology · 129d
Cleared Apr 11, 2014
DECLIPSESPECT LAPAROSCOPY
K133781 · IZD
Surgiceye GmbH
Radiology · 120d
Cleared Apr 11, 2014
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
K133923 · MUD
Reflectance Medical, Inc.
Cardiovascular · 109d
Cleared Apr 11, 2014
INION FREEDOMPIN
K133932 · HTY
Inion OY
Orthopedic · 109d
Cleared Apr 11, 2014
M-PM-DISC
K134015 · MQC
Merz Dental GmbH
Dental · 105d
Cleared Apr 11, 2014
DAYTONA ICG (P200TICG)
K134039 · MYC
Optos Plc.
Ophthalmic · 101d
Cleared Apr 11, 2014
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND...
K134047 · HCZ
Integra LifeSciences Corporation
Obstetrics & Gynecology · 101d