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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121657–121680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1991
AMS 3000 PORTABLE JET VENTILATOR
K900744 · CBK
Acutronic Medical Systems AG
Anesthesiology · 437d
Cleared Apr 29, 1991
VS-200S JET VENTILATOR
K900745 · CBK
Acutronic Medical Systems AG
Anesthesiology · 437d
Cleared Apr 29, 1991
OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12
K900880 · ITX
Olympus Corp.
Radiology · 427d
Cleared Apr 29, 1991
NORLAND XR26 WHOLE BODY OPTION
K901804 · KGI
Norland Corp.
Radiology · 374d
Cleared Apr 29, 1991
ORTHODONTIC BONDING ADHESIVE CONTROL
K904090 · DYH
Lancer Orthodontics, Inc.
Dental · 235d
Cleared Apr 29, 1991
MULTILAB 2000
K904392 · JAF
Unetixs, Inc.
Radiology · 217d
Cleared Apr 29, 1991
BC 1208 IMPLANT, THREADED EXTERNAL HEX
K904707 · DZE
Minimatic Implant Technology
Dental · 195d
Cleared Apr 29, 1991
S5192R TRANSDUCER
K904951 · MAA
Acuson Corp.
Radiology · 178d
Cleared Apr 29, 1991
IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER
K905039 · DZE
Minimatic Implant Technology
Dental · 174d
Cleared Apr 29, 1991
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
K905495 · HIG
Frigitronics, Inc.
Obstetrics & Gynecology · 143d
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