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
74017–74040 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2002
PHILIPS HARMONY RELEASE 1
K022788 · LLZ
Philips Medical Systems North America...
Radiology · 64d
Cleared Oct 25, 2002
VIZDEXTER VERSION 2.0
K022938 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 51d
Cleared Oct 25, 2002
CLEARFIL AP-X PLT
K023002 · EBF
Kuraray Medical, Inc.
Dental · 46d
Cleared Oct 25, 2002
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K023217 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Oct 25, 2002
VARISOURCE BREAST TEMPLATE SYSTEM
K023220 · JAQ
Varian Medical Systems
Radiology · 28d
Cleared Oct 25, 2002
INFUSION CATHETER EXTENSION SET
K023224 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
K023302 · MEH
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Oct 25, 2002
LEFORTE SYSTEM BONE PLATE
K023360 · KTW
Jeil Medical Corporation
Orthopedic · 18d
Cleared Oct 25, 2002
MODIFICATION TO ESOP CO-CR FEMORAL HEADS
K023375 · LPH
Pro-Active Healthcare
Orthopedic · 17d
Cleared Oct 25, 2002
EBI XFIX DFS SYSTEM
K023399 · KTT
Ebi, L.P.
Orthopedic · 16d
Cleared Oct 25, 2002
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
K023420 · NFB
Medical Electronic Devices, Inc.
Anesthesiology · 14d
Cleared Oct 25, 2002
VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE
K023428 · LZA
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 14d
Cleared Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND...
K020831 · GJS
Roche Diagnostics Corp.
Hematology · 224d
Cleared Oct 24, 2002
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD...
K021250 · EBF
Handpiece Unlimited
Dental · 188d
Cleared Oct 24, 2002
GYRUS ENT NERVE STIMULATOR
K021595 · ETN
Gyrus Ent LLC
Ear, Nose, Throat · 162d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
K021689 · CBF
Pan-America Hyperbarics, Inc.
Anesthesiology · 154d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
K021690 · CBF
Pan-America Hyperbarics, Inc.
Anesthesiology · 155d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
K021693 · CBF
Pan-America Hyperbarics, Inc.
Anesthesiology · 155d
Cleared Oct 24, 2002
INRATIO SELF-TEST
K021923 · GJS
Hemosense, Inc.
Hematology · 135d
Cleared Oct 24, 2002
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
K022217 · EIA
Aseptico, Inc.
Dental · 108d
Cleared Oct 24, 2002
CARDIO ID+(RZ153+)
K022540 · DSH
Rozinn Electronics, Inc.
Cardiovascular · 84d
Cleared Oct 24, 2002
SPOT PRO (220V), MODEL 131.099
K022741 · MUJ
Nucletron Corporation
Radiology · 66d
Cleared Oct 24, 2002
CLEARFIL AP-X PLT INTRO KIT
K022999 · EBF
Kuraray Medical, Inc.
Dental · 45d
Cleared Oct 24, 2002
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
K023058 · KXT
Seradyn
Toxicology · 41d