FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

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

Filters: Cleared only ×
175,230 results
120841–120864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1991
PX COULTER(R) CELL CONTROL
K912133 · JPK
Coulter Electronics, Inc.
Hematology · 64d
Cleared Jul 17, 1991
XY IMAGING TABLE
K912135 · IYZ
Med-Tron Products, Inc.
Radiology · 64d
Cleared Jul 17, 1991
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT
K912150 · GTQ
Beckman Instruments, Inc.
Microbiology · 63d
Cleared Jul 17, 1991
E-Z LIFT CRANK IMAGING TABLE
K912181 · IYZ
Med-Tron Products, Inc.
Radiology · 62d
Cleared Jul 17, 1991
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165
K912386 · CEF
Helena Laboratories
Chemistry · 82d
Cleared Jul 17, 1991
MODELS 5,8,20,20S ARGON ION LASERS
K912438 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 44d
Cleared Jul 17, 1991
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K912440 · CGA
Home Diagnostics, Inc.
Chemistry · 44d
Cleared Jul 17, 1991
LINEARITY TEST KITS
K912441 · JJY
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Jul 17, 1991
NOVA 12 ANALYZER
K912560 · JGS
Nova Biomedical Corp.
Chemistry · 36d
Cleared Jul 17, 1991
SYNERMED PHOSPHORUS REAGENT KIT
K912569 · CEO
Synermed, Inc.
Chemistry · 36d
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