FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
121441–121464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1991
ISE/CI-
K912647 · CGZ
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Jul 17, 1991
ISE/NA+
K912648 · JGS
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Jul 17, 1991
AMERLITE CK-MB ASSAY
K912766 · JHY
Amersham Corp.
Chemistry · 23d
Cleared Jul 17, 1991
W-H TOPAIR DENTAL HANDPIECE
K912786 · EFB
Sabra-The Dental Products Group
Dental · 23d
Cleared Jul 17, 1991
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
K912967 · JOH
Bivona Medical Technologies
Anesthesiology · 9d
Cleared Jul 16, 1991
LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100
K910418 · HGM
Graphic Controls Corp.
Obstetrics & Gynecology · 167d
Cleared Jul 16, 1991
PATIENT WARMER MODEL 100C
K910915 · FMT
Developmed Corp.
General Hospital · 133d
Cleared Jul 16, 1991
EMPTY I.V. CONTAINER
K910936 · KPE
Ellis Pharmaceutical Consulting, Inc.
General Hospital · 132d
Cleared Jul 16, 1991
VERSA-STIM ELECTRODE LINE MODIFIED
K911069 · GXY
Conmedcorp
Neurology · 127d
Cleared Jul 16, 1991
SOPUR GMBH WHEELCHAIRS
K911119 · IOR
Sopur GmbH
Physical Medicine · 127d
Cleared Jul 16, 1991
M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST)
K911718 · JDI
Biomet, Inc.
Orthopedic · 90d
Cleared Jul 15, 1991
VIEWNET
K905578 · LNH
Imagenet
Radiology · 215d
Cleared Jul 15, 1991
BARD AMBULATORY PUMP TUBING SET
K905713 · FRN
C.R. Bard, Inc.
General Hospital · 206d
Cleared Jul 15, 1991
TBD
K910081 · KPI
Empi
Gastroenterology & Urology · 187d
Cleared Jul 15, 1991
VASCULAR BIOPSY FORCEPS
K910840 · DWZ
Vascular Products, Inc.
Cardiovascular · 138d
Cleared Jul 15, 1991
FC2000
K911454 · JAA
S & S Inficon, Inc.
Radiology · 103d
Cleared Jul 15, 1991
XYZ IMAGING TABLE WITH FOOT PUMP
K911561 · IYZ
Med-Tron Products, Inc.
Radiology · 97d
Cleared Jul 15, 1991
E-Z LIFT IMAGING TABLE WITH FOOT PUMP
K911564 · IYZ
Med-Tron Products, Inc.
Radiology · 97d
Cleared Jul 15, 1991
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP
K911685 · JDI
Biomet, Inc.
Orthopedic · 90d
Cleared Jul 15, 1991
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
K911686 · HSD
Depuy, Inc.
Orthopedic · 90d
Cleared Jul 15, 1991
ISE/K+
K912649 · CEM
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Jul 12, 1991
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
K905778 · FRN
Baxter Healthcare Corp
General Hospital · 197d
Cleared Jul 12, 1991
MEDFLATOR INFLATION SYSTEM
K910958 · MAV
Medex, Inc.
Cardiovascular · 128d
Cleared Jul 12, 1991
SURGICAL GLOVES
K911134 · KGO
Kenwell International , Ltd.
General Hospital · 120d