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
122233–122256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1991
MATRICS
K904756 · ESD
Kerr Corporation (Danbury)
Ear, Nose, Throat · 147d
Cleared Mar 15, 1991
MOTOR DRIVEN EXTIRPATION INSTRUMENTS
K904859 · HRX
Aesculap, Inc.
Orthopedic · 137d
Cleared Mar 15, 1991
PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
K904937 · HEB
Playtex Family Products, Inc.
Obstetrics & Gynecology · 134d
Cleared Mar 15, 1991
ACETATE CONCENTRATES FOR HEMODIALYSIS
K905021 · KPO
Medical Components, Inc.
Gastroenterology & Urology · 128d
Cleared Mar 15, 1991
MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL
K905032 · ELW
Parkell
Dental · 128d
Cleared Mar 15, 1991
NERVE LOCATOR/STIMULATOR
K905045 · ETN
Aaron Medical Industries
Ear, Nose, Throat · 127d
Cleared Mar 15, 1991
INJECTOR, INSULIN
K905062 · KZE
Sound 2000 Medical Systems, Inc.
General Hospital · 126d
Cleared Mar 15, 1991
SENTRY SCALE
K905122 · FRW
Apollo Enterprise, Ltd. Co.
General Hospital · 121d
Cleared Mar 15, 1991
DURAFILL COLOR VS
K905131 · EBF
Kulzer, Inc.
Dental · 120d
Cleared Mar 15, 1991
FLOSCOPE VASCULAR LAB.
K905157 · JOP
Advance Medical Device, Inc.
Cardiovascular · 119d
Cleared Mar 15, 1991
ITE HEARING AID
K905371 · ESD
Audicare Hearing Center
Ear, Nose, Throat · 106d
Cleared Mar 15, 1991
VIAL ACCESS CANNULA
K905664 · FMI
Baxter Healthcare Corp
General Hospital · 87d
Cleared Mar 15, 1991
KRUPIN EYE VALVE WITH DISK
K905703 · KYF
Hood Laboratories
Ophthalmic · 85d
Cleared Mar 15, 1991
IONOSEAL
K905723 · EJK
Micro-Vac, Inc.
Dental · 85d
Cleared Mar 15, 1991
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
K905728 · DPT
Hewlett-Packard Co.
Cardiovascular · 81d
Cleared Mar 15, 1991
GDC-3200 DENTAL SOLDER
K910065 · EJT
Deringer-Ney, Inc.
Dental · 65d
Cleared Mar 15, 1991
SPECTRAMAT
K910068 · EBZ
Ivoclar North America, Inc.
Dental · 65d
Cleared Mar 15, 1991
OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT)
K910134 · HQZ
Kentucky Optical Co.
Ophthalmic · 65d
Cleared Mar 15, 1991
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST
K910260 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 52d
Cleared Mar 15, 1991
HELICAL SCAN
K910375 · JAK
Toshiba America Medical Systems, In.C
Radiology · 45d
Cleared Mar 15, 1991
7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS
K910529 · ITX
Siemens Ultrasound, Inc.
Radiology · 35d
Cleared Mar 15, 1991
ACCU-MIX AMALGAMATOR
K910632 · EFD
Wykle Research, Inc.
Dental · 30d
Cleared Mar 15, 1991
5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU
K910669 · ITX
Siemens Ultrasound, Inc.
Radiology · 28d
Cleared Mar 15, 1991
ENAMEL ETCHING GEL
K910803 · DYH
Gresco Products, Inc.
Dental · 17d