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
117145–117168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1992
LAPAROCOPIC MYOMA SCREW
K915388 · HHO
Cook Urological, Inc.
Obstetrics & Gynecology · 171d
Cleared May 18, 1992
HYSTEROSCOPIC MYOMA SCREW
K915412 · HHO
Cook Urological, Inc.
Obstetrics & Gynecology · 168d
Cleared May 18, 1992
DISPOSABLE POSTERIOR MICROSCISSORS
K920718 · HQE
Storz Instrument Co.
Ophthalmic · 90d
Cleared May 18, 1992
FELDMUHLE CERAMIC HEAD
K920756 · LZO
Link America, Inc.
Orthopedic · 89d
Cleared May 18, 1992
PHILIPS BV26 MOBILE C-ARM STAND
K921255 · OXO
Philips Medical Systems, Inc.
Radiology · 63d
Cleared May 18, 1992
M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION
K921278 · LMD
Metecon, Inc.
Radiology · 62d
Cleared May 18, 1992
TELEX MODEL M29 ITE CUSTOM HEARING AID
K922065 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 14d
Cleared May 18, 1992
TELEX MODEL 28A ITE CUSTOM HEARING AID
K922066 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 14d
Cleared May 15, 1992
ULTRACALM
K910625 · LWM
Sion Technology, Inc.
Dental · 458d
Cleared May 15, 1992
ACCESSORY TO GENESIS III (GCFM)
K913209 · DXK
Biosound, Inc.
Radiology · 301d
Cleared May 15, 1992
OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM
K914565 · JWH
Osteonics Corp.
Orthopedic · 213d
Cleared May 15, 1992
INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH
K915202 · LOS
Siemens Burdick, Inc.
Cardiovascular · 179d
Cleared May 15, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY)
K915567 · LNH
Fonar Corp.
Radiology · 155d
Cleared May 15, 1992
INJECTION SITE WITH LUER LOCK
K915828 · FPA
Baxter Healthcare Corp
General Hospital · 137d
Cleared May 15, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K920094 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared May 15, 1992
OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION
K920524 · JWH
Osteonics Corp.
Orthopedic · 100d
Cleared May 15, 1992
HOWEDICA ZIRCONIA FEMORAL HEAD
K920577 · LZO
Howmedica Corp.
Orthopedic · 95d
Cleared May 15, 1992
AEROSOL DELIVERY SYSTEMS
K920842 · LRD
Hospitak, Inc.
Ear, Nose, Throat · 81d
Cleared May 15, 1992
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
K920949 · GKZ
Heraeus Kulzer, Inc.
Hematology · 74d
Cleared May 15, 1992
ATMOS MIRROR WARMER
K920988 · LRC
Jedmed Instrument Co.
Ear, Nose, Throat · 74d
Cleared May 15, 1992
HOOD NASAL SEPTAL BUTTON
K920994 · LFB
Hood Laboratories
Ear, Nose, Throat · 74d
Cleared May 15, 1992
PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)
K921085 · EWO
Hear-Well Technologies, Inc.
Ear, Nose, Throat · 70d
Cleared May 15, 1992
MAGNETOM 63SP
K921098 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared May 15, 1992
PHILIPS INTEGRIS V3000 FILM
K921101 · IZI
Philips Medical Systems, Inc.
Radiology · 67d