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
78193–78216 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 31, 2001
INTERCEPT-URETHRAL MICROCOIL
K011781 · MOS
Surgi-Vision, Inc.
Radiology · 85d
Cleared Aug 31, 2001
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
K011873 · LNS
Dornier
Gastroenterology & Urology · 77d
Cleared Aug 31, 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912 · MBI
Axya Medical, Inc.
Orthopedic · 73d
Cleared Aug 31, 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162 · HRS
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
K012292 · CFN
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
K012296 · CFN
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 31, 2001
COALESCENT SURGICAL U-CLIP
K012317 · FZP
Coalescent Surgical
General & Plastic Surgery · 39d
Cleared Aug 31, 2001
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
K012476 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 29d