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
106081–106104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1994
PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069
K942476 · FXX
Protectaide, Inc.
General Hospital · 146d
Cleared Oct 18, 1994
GC PATTERN RESIN
K942670 · EBG
GC America, Inc.
Dental · 134d
Cleared Oct 18, 1994
FLEXIBLE FIBER OPTIC LAPAROSCOPES
K943598 · HET
Optimed Technologies, Inc.
Obstetrics & Gynecology · 84d
Cleared Oct 18, 1994
IMPLANTECH TEMPORAL IMPLANT
K943644 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 83d
Cleared Oct 18, 1994
MARQUETTE ADULT/NEONATAL WRAP SENSOR
K943817 · DQA
Marquette Electronics, Inc.
Anesthesiology · 74d
Cleared Oct 18, 1994
VINYL EXAMINATION GLOVE, POWDER-FREE
K944510 · LYZ
American Gemini, Inc.
General Hospital · 33d
Cleared Oct 18, 1994
MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
K944560 · JEY
KLS-Martin L.P.
Dental · 32d
Cleared Oct 18, 1994
MICRO OSTEOSYNTHESIS SYSTEM (1.0)
K944561 · JEY
KLS-Martin L.P.
Dental · 32d
Cleared Oct 18, 1994
KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)
K944565 · JEY
KLS-Martin L.P.
Dental · 32d
Cleared Oct 17, 1994
FRESENIUS DIALYSATE ACID CONCENTRATE
K922088 · KPO
Fresenius USA, Inc.
Gastroenterology & Urology · 896d
Cleared Oct 17, 1994
MALIBU BATHING SYSTEM
K925195 · ILJ
Medi-Man Rehabilitation Products, Inc.
Physical Medicine · 732d
Cleared Oct 17, 1994
HYSTEROMED 100
K930912 · HIG
Northgate Technologies, Inc.
Obstetrics & Gynecology · 602d
Cleared Oct 17, 1994
PAM CARDIAC MONITOR
K934684 · DRT
Technology Transfer, Inc.
Cardiovascular · 382d
Cleared Oct 17, 1994
CAPNOCHECK
K941982 · CCK
Bci, Inc.
Anesthesiology · 175d
Cleared Oct 17, 1994
PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM
K942871 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 122d
Cleared Oct 17, 1994
AMSCO SQ240 SURGICAL LIGHT
K943288 · FSY
American Sterilizer Co.
General & Plastic Surgery · 101d
Cleared Oct 17, 1994
MEDICAM XENON LIGHT SOURCE
K943342 · FSW
M.P. Video, Inc.
General & Plastic Surgery · 97d
Cleared Oct 17, 1994
AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT
K943456 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 91d
Cleared Oct 17, 1994
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586 · LZO
Biomet, Inc.
Orthopedic · 87d
Cleared Oct 17, 1994
BEDSIDE BUTLER
K944345 · IQA
Trac Medical, Inc.
Physical Medicine · 41d
Cleared Oct 17, 1994
LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)
K944574 · IOR
Lumex, Inc.
Physical Medicine · 28d
Cleared Oct 17, 1994
DURA-Y OXYGEN TRANSDUCER, EAR CLIP
K944760 · DPZ
Nellcor, Inc.
Anesthesiology · 20d
Cleared Oct 17, 1994
2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE
K944849 · DRX
Conmed Andover Medical, Inc.
Cardiovascular · 17d
Cleared Oct 14, 1994
MUMPS STAT
K925209 · LJY
Biowhittaker Molecular Applications,...
Microbiology · 737d