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
134929–134952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1988
SYRINGE PREFILLED WITH WATER
K881363 · KOD
I M, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 23, 1988
CPR BAG
K881686 · BTM
Devolve Corp.
Anesthesiology · 65d
Cleared Jun 23, 1988
DESERET SUBCLAVIAN HEMODIALYSIS CATHETER
K881695 · LFJ
Deseret Medical, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 23, 1988
VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER
K881743 · LFJ
Vas-Cath, Inc.
Gastroenterology & Urology · 62d
Cleared Jun 23, 1988
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT
K882244 · EPP
Richards Medical Co., Inc.
Ear, Nose, Throat · 23d
Cleared Jun 23, 1988
STORZ DIAGNOSTIC MICROSCOPE SYSTEM
K882269 · EPT
Storz Instrument Co.
General & Plastic Surgery · 23d
Cleared Jun 23, 1988
COVER, SHOE OPERATING ROOM
K882280 · FXP
A Plus International, Inc.
General Hospital · 23d
Cleared Jun 23, 1988
GOWN, ISOLATION, SURGICAL (FYC)
K882281 · FYC
A Plus International, Inc.
General Hospital · 23d
Cleared Jun 23, 1988
SUIT, SURGICAL
K882282 · FXO
A Plus International, Inc.
General Hospital · 23d
Cleared Jun 23, 1988
BOUFFANT CAP
K882283 · FYF
A Plus International, Inc.
General & Plastic Surgery · 23d
Cleared Jun 23, 1988
SURGEONS CAP
K882284 · FYF
A Plus International, Inc.
General & Plastic Surgery · 23d
Cleared Jun 23, 1988
THE DIRECTION DIAL
K882309 · EKJ
Lawhorn Innovations
Dental · 20d
Cleared Jun 23, 1988
FLOOR LIGHT
K882333 · FSS
Commercial Products & Engineering Co.
General & Plastic Surgery · 17d
Cleared Jun 23, 1988
MALLET, SURGICAL
K882349 · HXL
Treace Medical, Inc.
General & Plastic Surgery · 16d
Cleared Jun 22, 1988
HIGH PERFORMANCE CALIBRATORS
K875216 · DKB
Rapid Diagnostic Laboratories, Inc.
Toxicology · 183d
Cleared Jun 22, 1988
HYDROCOLLOID DRESSING FOR PSORIASIS
K881039 · FRO
Hollister, Inc.
General & Plastic Surgery · 103d
Cleared Jun 22, 1988
ACCUSTAT MODEL 102 NON-INVASIVE BLOOD MONITORING
K881272 · DXN
Accustat, Inc.
Cardiovascular · 90d
Cleared Jun 22, 1988
MINI-TEMP(TM)
K881322 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 86d
Cleared Jun 22, 1988
MCCAIN MONOPOLAR & BIPOLAR CAUTERY
K881403 · GEI
Walter Lorenz Surgical, Inc.
General & Plastic Surgery · 79d
Cleared Jun 22, 1988
METATECH METAL MICROCLIP
K881447 · DXC
Metatech Corp.
Cardiovascular · 77d
Cleared Jun 22, 1988
VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT
K881504 · DQY
Hdc Corp.
Cardiovascular · 72d
Cleared Jun 22, 1988
HJD CALCAR REPLACEMENT PROSTHESIS
K881769 · JDI
Richards Medical Co., Inc.
Orthopedic · 65d
Cleared Jun 22, 1988
HEALTHTRONIC OMEGA TRAC
K881902 · JFB
Healthtronics Surgical Services, Inc.
Physical Medicine · 47d
Cleared Jun 22, 1988
MICROCIRRUS MEDICAL NEBULIZER
K881935 · CAF
Dhd Medical Products Div. Diemolding...
Anesthesiology · 44d