FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122257–122280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1991
POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND
K905582 · EBC
Milton Hodosh, M.D.
Dental · 138d
Cleared Apr 29, 1991
NEW TRIAD TRANSHEET DENTURE BASE MATERIAL
K905702 · EBI
Dentsply Intl.
Dental · 130d
Cleared Apr 29, 1991
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
K905787 · LJC
Vitek Systems, Inc.
Microbiology · 123d
Cleared Apr 29, 1991
INTERSPEC APOGEE, MODIFICATION
K910049 · DPW
Interspec, Inc.
Cardiovascular · 112d
Cleared Apr 29, 1991
LAPAROSCOPIC IRRIGATOR/ASPIRATOR
K910209 · HET
Solos Mfg.
Obstetrics & Gynecology · 104d
Cleared Apr 29, 1991
CORE DISPOSABLE SUCTION/IRRIGATION TUBING
K910246 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 97d
Cleared Apr 29, 1991
BRONCHOSCOPE BF-N20
K910423 · EOQ
Olympus Corp.
Ear, Nose, Throat · 89d
Cleared Apr 29, 1991
PERMANENT SILICONE CATHETERS
K910501 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 29, 1991
VESSEL DILATORS
K910502 · FKA
Akcess Medical Products, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 29, 1991
DISPOSAL PAD FOR SHARPS
K910516 · MMK
Visitec Co.
General Hospital · 83d
Cleared Apr 29, 1991
PIGGY LOCK NEEDLE HOUSING
K910546 · FPA
Icu Medical, Inc.
General Hospital · 82d
Cleared Apr 29, 1991
BARRIER* EXTRA PROTECTION PLUS FACE MASK
K910557 · FXX
Johnson & Johnson Medical, Inc.
General Hospital · 80d
Cleared Apr 29, 1991
INJECTION CAPS
K910572 · FOZ
Akcess Medical Products, Inc.
General Hospital · 77d
Cleared Apr 29, 1991
ABS CADKIT
K910636 · GIS
Panbio, Inc.
Hematology · 75d
Cleared Apr 29, 1991
INTRODUCER NEEDLES
K910641 · KOC
Akcess Medical Products, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 29, 1991
J&S PEDIATRIC IRON SATURATING REAGENT
K910672 · JQE
J.S. Medical Assoc.
Chemistry · 73d
Cleared Apr 29, 1991
IMMULITE(TM) T-UPTAKE
K910677 · CEE
Cirrus Diagnostics, Inc.
Chemistry · 73d
Cleared Apr 29, 1991
SILICOATER MD
K910719 · EMA
Kulzer, Inc.
Dental · 68d
Cleared Apr 29, 1991
HEPARIN CONTROLS, HIGH AND LOW
K910741 · KFF
Sigma Diagnostics, Inc.
Hematology · 67d
Cleared Apr 29, 1991
ALL-BOND 2
K910860 · KLE
Bisco, Inc.
Dental · 68d
Cleared Apr 29, 1991
CIBA CORNING ACS T UPTAKE IMMUNOASSAY
K911093 · KHQ
Ciba Corning Diagnostics Corp.
Chemistry · 48d
Cleared Apr 29, 1991
UST-974-5 CONVEX TRANSDUCER
K911309 · ITX
Ge Medical Systems Information...
Radiology · 35d
Cleared Apr 29, 1991
INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA
K911316 · GEI
Northgate Technologies, Inc.
General & Plastic Surgery · 34d
Cleared Apr 29, 1991
RUBENOSTIKA IGG MICROELISA SYSTEM
K911393 · LFX
Organon Teknika Corp.
Microbiology · 31d