FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135745–135768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1988
MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE
K881585 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS
K881586 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS
K881587 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-25 LASER FOR SURGICAL USE
K881588 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER
K881673 · JEC
Lima-Lto, Inc.
Orthopedic · 46d
Cleared Jun 03, 1988
STUART LEE CLIP
K881741 · GDJ
Stuart-Lee, Inc.
General & Plastic Surgery · 42d
Cleared Jun 03, 1988
VIGGO VASCUPORT NEEDLE
K881758 · FMI
Ohmeda Medical
General Hospital · 39d
Cleared Jun 03, 1988
HARE ANY LEVEL COT
K881845 · FPO
Dyna Industries, Inc.
General Hospital · 32d
Cleared Jun 03, 1988
DRIPRIDE DISPOSABLE UNDERPAD
K881859 · KME
Weyerhaeuser Co.
General Hospital · 31d
Cleared Jun 03, 1988
SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI.
K881952 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 24d
Cleared Jun 03, 1988
SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU
K881953 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 24d
Cleared Jun 03, 1988
MSI 2005 SERIES BED
K881962 · FNJ
Med Service, Inc.
General Hospital · 24d
Cleared Jun 03, 1988
COBB SPINAL ELEVATORS
K882068 · KWP
Karlin Technology, Inc.
Orthopedic · 17d
Cleared Jun 03, 1988
LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORS
K882070 · KWP
Karlin Technology, Inc.
Orthopedic · 17d
Cleared Jun 02, 1988
VITALOGRAPH-EC60 HYDROGEN MONITOR
K874892 · NRH
Vitalograph , Ltd.
Chemistry · 184d
Cleared Jun 02, 1988
INTRO-REDUCER (NASOGASTRIC TUBE)
K875232 · KNT
Health Improvement Assoc.
Gastroenterology & Urology · 163d
Cleared Jun 02, 1988
WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION
K880879 · DQK
Ppg Industries, Inc.
Cardiovascular · 93d
Cleared Jun 02, 1988
HYGEIA GC TEST
K881064 · LIR
Hygeia Sciences
Microbiology · 80d
Cleared Jun 02, 1988
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS
K881436 · JJY
Hichem Diagnostics
Chemistry · 58d
Cleared Jun 02, 1988
DIAMOND'S MEDIUM MODIFIED
K881995 · KZI
Remel Co.
Microbiology · 21d
Cleared Jun 02, 1988
MODIFIED SHARPLAN MODEL 1020 CO2 LASER
K882180 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 30d
Cleared Jun 01, 1988
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
K873214 · DPT
General Electric Co.
Cardiovascular · 292d
Cleared Jun 01, 1988
NEUROPROBE
K874018 · ETN
Inovx, Inc.
Ear, Nose, Throat · 243d
Cleared Jun 01, 1988
ACCUCOM 2
K874138 · DPT
Datascope Corp.
Cardiovascular · 232d