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
135145–135168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1988
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326
K882182 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 13d
Cleared Jun 03, 1988
BION CMV-G TEST SYSTEM
K880679 · GQH
Bion Ent., Ltd.
Microbiology · 105d
Cleared Jun 03, 1988
LIFEPORT II, MODEL LPS-1100
K881075 · LJT
Strato Medical Corp.
General Hospital · 81d
Cleared Jun 03, 1988
SPEC 5* SUPRAPUBIC CATHETER
K881097 · KOB
Porges Corp.
Gastroenterology & Urology · 80d
Cleared Jun 03, 1988
ENTERA* ENTERAL FEEDING BAG
K881162 · KNT
Smash Ent., Inc.
Gastroenterology & Urology · 77d
Cleared Jun 03, 1988
MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY
K881580 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE
K881581 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE
K881582 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT
K881583 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE
K881584 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 53d
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