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

Filters: Cleared only ×
176,076 results
78793–78816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 04, 2001
MODIFICATION TO N/T PROTEIN CONTROL SL
K012468 · JJY
Dade Behring, Inc.
Chemistry · 33d
Cleared Sep 04, 2001
MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET...
K012541 · LDJ
Branan Medical Corp.
Toxicology · 28d
Cleared Sep 04, 2001
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
K012799 · GEI
Senorx, Inc.
General & Plastic Surgery · 14d
Cleared Aug 31, 2001
STRYKER NAVIGATION SYSTEM-KNEE MODULE
K010204 · HAW
Stryker Corp.
Neurology · 220d
Cleared Aug 31, 2001
MBI PD-103 SL
K011427 · KXK
Mills Biopharmaceuticals, Inc.
Radiology · 115d
Cleared Aug 31, 2001
TENS CARE, MODEL XL-Y3
K011543 · GZJ
Tenscare, Ltd.
Neurology · 105d
Cleared Aug 31, 2001
OLYMPUS SUCTION PUMP, MODEL KV-5
K011725 · JCX
Keymed (Medical & Industrial...
General & Plastic Surgery · 88d