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
143425–143448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1986
STREAM-SWITCH MANIFOLD
K861209 · FRN
Intelligent Medicine, Inc.
General Hospital · 84d
Cleared Jun 23, 1986
SARNS PORTABLE POWER MODULE
K861388 · DTQ
3M Health Care, Sarns
Cardiovascular · 70d
Cleared Jun 23, 1986
ST-90 SPIRO ANALIZER
K861487 · BTY
Future Impex Corp.
Anesthesiology · 73d
Cleared Jun 23, 1986
MODEL PC HEARING AID
K861939 · ESD
Fine-Tune
Ear, Nose, Throat · 34d
Cleared Jun 23, 1986
PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM
K862021 · HQC
Ultramed, Inc.
Ophthalmic · 26d
Cleared Jun 23, 1986
MODEL HP HEARING AID
K862036 · ESD
Fine-Tune
Ear, Nose, Throat · 25d
Cleared Jun 23, 1986
LIFESOUND CUSTOM ITE
K862050 · ESD
Lifesounds, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 23, 1986
DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID
K862099 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL ED BEHIND-THE-EAR HEARING AID
K862100 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UM IN-THE-CANAL HEARING AID
K862101 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL KM IN-THE-CANAL HEARING AID
K862102 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UC IN-THE-CANAL HEARING AID
K862103 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UC SPECTRUM IN-THE-CANAL HEARING AID
K862104 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
LIFECARE REMOTE ALARM #34-001
K862212 · CBK
Lifecare Services, Inc.
Anesthesiology · 13d
Cleared Jun 23, 1986
SHOFU LINING CEMENT
K862280 · EMA
Shofu Dental Corp.
Dental · 7d
Cleared Jun 23, 1986
SEALITE
K862284 · EBC
Sybron Corp.
Dental · 7d
Cleared Jun 20, 1986
SDL-300
K854337 · ITX
Shimadzu Corp.
Radiology · 235d
Cleared Jun 20, 1986
PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC
K854468 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 226d
Cleared Jun 20, 1986
PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC
K854473 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 226d
Cleared Jun 20, 1986
MEDNOVA BLOOD PRESSURE CUFF
K854813 · DXQ
Mednova Corp.
Cardiovascular · 199d
Cleared Jun 20, 1986
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
K861499 · DAK
Biostar Medical Products, Inc.
Immunology · 58d
Cleared Jun 20, 1986
#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL
K861903 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 35d
Cleared Jun 20, 1986
WHITE OAK ALLERGEN DISC
K862175 · DHB
Immuno Nuclear Corp.
Immunology · 11d
Cleared Jun 20, 1986
PERSUNAL TAN, MODEL NO. HU-0208L
K862263 · FTC
Sunthetic Engineering, Inc.
General & Plastic Surgery · 7d