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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77665–77688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 04, 2001
DC - CRISTAL
K011674 · EIH
Austenal, Inc.
Dental · 97d
Cleared Sep 04, 2001
NOVEL PRINT CYAN ALGINATES
K011785 · ELW
Manufacturera Dental Continental
Dental · 88d
Cleared Sep 04, 2001
TOKUYAMA M-BOND
K011854 · EMA
Tokuyama America, Inc.
Dental · 83d
Cleared Sep 04, 2001
ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
K011868 · LZH
Debio Tech SA
General Hospital · 82d
Cleared Sep 04, 2001
VENTVIEW, MODEL 8414095
K012177 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 54d
Cleared Sep 04, 2001
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
K012392 · DSA
Pace Medical
Cardiovascular · 39d
Cleared Sep 04, 2001
EXTRUDE MODIFIED
K012405 · ELW
Sybron Dental Specialties, Inc.
Dental · 36d
Cleared Sep 04, 2001
MODIFICATION TO CLEARFIL PHOTO BOND
K012432 · KLE
Kuraray Medical, Inc.
Dental · 35d
Cleared Sep 04, 2001
MODIFICATION TO ALLOY PRIMER
K012436 · KLE
Kuraray Medical, Inc.
Dental · 35d