Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
74617–74640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2002
SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD...
K022477 · CAK
Summit Medical , Ltd.
General Hospital · 88d
Cleared Oct 25, 2002
COOK INJECTION NEEDLE
K022484 · FBK
Cook Urological, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 25, 2002
UTERINE INJECTOR
K022503 · LKF
Thomas Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 25, 2002
MEDCOMP VASCU-SHEATH INTRODUCER SET
K022513 · DYB
Medcomp
Cardiovascular · 87d
Cleared Oct 25, 2002
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
K022604 · LYZ
Sun Flower Gloves Co., Ltd.
General Hospital · 80d
Cleared Oct 25, 2002
HELIX HYDRO-JET
K022613 · FQH
Erbe USA, Inc.
General Hospital · 80d
Cleared Oct 25, 2002
SPSMEDICAL SPORVIEW STEAM BI TEST PACK
K022706 · FRC
Spsmedical Supply Corp.
General Hospital · 72d
Cleared Oct 25, 2002
REAL TIME HDR (220V), MODEL 132.001
K022739 · JAQ
Nucletron Corporation
Radiology · 67d
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