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
78169–78192 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2001
3.25MM SPLINE TWIST IMPLANT
K012055 · DZE
Sulzer Dental, Inc.
Dental · 66d
Cleared Sep 06, 2001
JAS CARBON DIOXIDE LIQUID REAGENT
K012332 · KHS
Jas Diagnostics, Inc.
Chemistry · 45d
Cleared Sep 06, 2001
LC TEMPORARY FILLING
K012360 · EBG
Parkell, Inc.
Dental · 43d
Cleared Sep 06, 2001
PANAVIA F
K012441 · EMA
Kuraray Medical, Inc.
Dental · 37d
Cleared Sep 06, 2001
VERASTEP
K012539 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 30d
Cleared Sep 06, 2001
MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
K012564 · HAW
Brainlab AG
Neurology · 28d
Cleared Sep 06, 2001
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · KPS
General Electric Co.
Radiology · 28d
Cleared Sep 06, 2001
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
K012584 · CAZ
Bd
Anesthesiology · 27d
Cleared Sep 06, 2001
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · JJT
Bio-Rad
Chemistry · 24d
Cleared Sep 05, 2001
JMS APHERESIS NEEDLE SET ACCORDION TYPE
K002394 · FMI
Jms Co., Ltd.
General Hospital · 394d
Cleared Sep 05, 2001
BRITESMILE BARRIER MATERIAL
K010935 · EIE
Britesmile, Inc.
Dental · 161d
Cleared Sep 05, 2001
OMNIDOS
K011763 · IYE
Scanditronix Medical AB
Radiology · 90d
Cleared Sep 05, 2001
R120 MODULAR TOTAL HIP SYSTEM
K011774 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Sep 05, 2001
MICROCRUISER PLUS INTRODUCER SET
K011790 · DYB
Medical Device Technologies, Inc.
Cardiovascular · 89d
Cleared Sep 05, 2001
DENTORIUM CONVERTIBLE ACRYLIC
K011820 · EBI
Nats Corp.
Dental · 86d
Cleared Sep 05, 2001
MHS 5000
K011981 · LHQ
Micro Health Systems, Inc.
Radiology · 72d
Cleared Sep 05, 2001
A-WEAR
K012180 · EBF
Bisco, Inc.
Dental · 55d
Cleared Sep 05, 2001
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342 · FZP
American Medical Systems, Inc.
General & Plastic Surgery · 43d
Cleared Sep 05, 2001
MODIFICATION TO PANAVIA 21
K012438 · EMA
Kuraray Medical, Inc.
Dental · 36d
Cleared Sep 05, 2001
MODIFICATION TO CLEARFIL LINER BOND 2V
K012440 · KLE
Kuraray Medical, Inc.
Dental · 36d
Cleared Sep 05, 2001
CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND...
K012573 · FLE
Getinge/Castle, Inc.
General Hospital · 27d
Cleared Sep 04, 2001
PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
K003548 · MKJ
Padpro, LLC
Cardiovascular · 291d
Cleared Sep 04, 2001
NEXAN SYSTEM, MODEL NX-301
K010424 · MWI
Nexan, Ltd.
Cardiovascular · 203d
Cleared Sep 04, 2001
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · KXK
Cp Medical
Radiology · 187d