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
96961–96984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1996
VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K960833 · FRA
Uv Technologies, Inc.
General Hospital · 147d
Cleared Jul 25, 1996
EXPERT SPINE MORPHOTIETRY REFERENCE
K961007 · KGI
Lunar Corp.
Radiology · 135d
Cleared Jul 25, 1996
KILTEX PROBE COVER
K961029 · IYO
Kiltex Corp.
Radiology · 133d
Cleared Jul 25, 1996
BODILY FLUID DISPOSAL KIT
K961217 · FXX
Transidyne General Corp.
General Hospital · 119d
Cleared Jul 25, 1996
KODAK MN-R 2000 CASSETTE
K961453 · IXA
Eastman Kodak Company
Radiology · 100d
Cleared Jul 25, 1996
AMMI MAGNI-GUARD
K961454 · LYU
American Medical Mfg., Inc.
General Hospital · 101d
Cleared Jul 25, 1996
MEDSHIELD/AEROCHAMBER
K961455 · CCQ
Diemolding Corp.
Anesthesiology · 100d
Cleared Jul 25, 1996
MINIOX 3000 OXYGEN MONITOR
K961644 · CCL
Minesafety Appliances Co.
Anesthesiology · 87d
Cleared Jul 25, 1996
BG PATIENT EXAMINATION GLOVES, NON-STERILE
K961675 · LYY
Biografik (Malaysia) Sdn Bhd
General Hospital · 90d
Cleared Jul 25, 1996
TK40 - TILTMASTER
K961744 · ITI
Mechanical Application Designs, Inc.
Physical Medicine · 110d
Cleared Jul 25, 1996
SHARED VISION(PART NUMBER SV 0015)
K961753 · LMD
Imagelabs, Inc.
Radiology · 80d
Cleared Jul 25, 1996
ECOGEL 100 ULTRASOUND GEL
K961757 · ITX
Eco-Med Pharmaceuticals, Inc.
Radiology · 80d
Cleared Jul 25, 1996
STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK
K961820 · HQC
Storz Instrument Co.
Ophthalmic · 76d
Cleared Jul 25, 1996
AIRIS
K961876 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 71d
Cleared Jul 25, 1996
TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
K961900 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 70d
Cleared Jul 25, 1996
READY-SET PUNCTAL PLUGS
K961909 · LZU
Fci Ophthalmics, Inc.
Ophthalmic · 70d
Cleared Jul 25, 1996
TOMOGRAPH ACCESSORIES
K962120 · EHD
Steri-Oss, Inc.
Radiology · 55d
Cleared Jul 25, 1996
ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC...
K962140 · JAA
Continental X-Ray Corp.
Radiology · 52d
Cleared Jul 25, 1996
MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
K962163 · ERL
Misten Medical Corp.
Ear, Nose, Throat · 51d
Cleared Jul 25, 1996
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
K962170 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 25, 1996
MLX MICROTITER PLATE LUMINOMETER
K962265 · JSE
Dynatech Laboratories, Inc.
Chemistry · 43d
Cleared Jul 25, 1996
CENTER OPTICAL GLASSES
K962298 · HQY
Mirage Eyewear, Inc.
Ophthalmic · 42d
Cleared Jul 25, 1996
ELITYS OR ELITYS-E
K962337 · EHD
Trophy Radiologie
Radiology · 38d
Cleared Jul 25, 1996
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
K962382 · HQY
Xiamen Chingsong Optical Industrial...
Ophthalmic · 35d