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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
116737–116760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1992
THYROXINE (T4) COATED TUBE RIA
K921935 · CDX
Monobind
Chemistry · 74d
Cleared Jul 06, 1992
A-ZILICONE
K905555 · ESD
Oticon Corp.
Ear, Nose, Throat · 573d
Cleared Jul 06, 1992
LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR)
K920990 · LDD
Raco Products Co.
Cardiovascular · 126d
Cleared Jul 06, 1992
COULTER MH017
K921567 · GKZ
Coulter Electronics, Inc.
Hematology · 95d
Cleared Jul 06, 1992
ECG MODULATOR
K922412 · DXH
Maguire Ent., Inc.
Cardiovascular · 46d
Cleared Jul 02, 1992
MULTISPIRO-BREEZE
K913681 · BZC
Multispiro, Inc.
Anesthesiology · 318d
Cleared Jul 02, 1992
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
K913749 · BZQ
Edentec Corp.
Anesthesiology · 316d
Cleared Jul 02, 1992
KOKO SPIROMETER
K914272 · BZG
Ferraris Respiratory, Inc.
Anesthesiology · 282d
Cleared Jul 02, 1992
URINARY DIVERSION EVACUATING CATHETER
K914692 · EXD
Cook Urological, Inc.
Gastroenterology & Urology · 258d
Cleared Jul 02, 1992
MULTISPIRO-SX
K915451 · BZG
Multispiro, Inc.
Anesthesiology · 210d
Cleared Jul 02, 1992
CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER
K915715 · IYO
Ausonics Pty , Ltd.
Radiology · 268d
Cleared Jul 02, 1992
LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE
K915860 · ITX
Biosound, Inc.
Radiology · 185d
Cleared Jul 02, 1992
DURATECH HOSPITAL TOWEL
K920045 · KKX
Techstyles
General Hospital · 178d
Cleared Jul 02, 1992
MININEB
K920443 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 150d
Cleared Jul 02, 1992
OPERATING TABLE SYSTEM-BETAMAQUET 1140
K920890 · FQO
Stierlen-Maquet AG
General & Plastic Surgery · 141d
Cleared Jul 02, 1992
MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER
K921298 · GEX
Cj Laser Corp.
General & Plastic Surgery · 107d
Cleared Jul 02, 1992
ELIOS DIODE OPHTHALMIC LASER
K921320 · GEX
Marco Ophthalmic, Inc.
General & Plastic Surgery · 105d
Cleared Jul 02, 1992
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
K921460 · HQE
Storz Instrument Co.
Ophthalmic · 97d
Cleared Jul 02, 1992
DENTAL PORCELAIN
K921619 · EIH
Dentsply Intl.
Dental · 87d
Cleared Jul 02, 1992
ALPHATEC COMPRESSION HIP SCREW SYSTEM
K921622 · HRS
Alphatec Mfg., Inc.
Orthopedic · 87d
Cleared Jul 02, 1992
VITADUR ALPHA PORCELAIN
K921623 · EIH
Vident
Dental · 87d
Cleared Jul 02, 1992
CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL
K921631 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 87d
Cleared Jul 02, 1992
BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM
K921639 · LPH
Zimmer, Inc.
Orthopedic · 87d
Cleared Jul 02, 1992
MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
K921654 · FGE
Cook, Inc.
Gastroenterology & Urology · 86d