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

Filters: Cleared only ×
175,820 results
135721–135744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1988
BUN (KINETIC)
K881677 · CDQ
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Jun 07, 1988
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K881693 · JIS
Terumo Medical Corp.
Chemistry · 49d
Cleared Jun 07, 1988
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
K881798 · CIG
Technicon Instruments Corp.
Chemistry · 41d
Cleared Jun 07, 1988
DRY COMFORT DISPOSABLE UNDERPAD
K881969 · KME
Health Tec, Inc.
General Hospital · 27d
Cleared Jun 06, 1988
DPX BONE DENSITOMETER
K873296 · KGI
Lunar Radiation Corp.
Radiology · 294d
Cleared Jun 06, 1988
EFFNER CAUTERY INSTRUMENTS
K875260 · HQP
Effner and Spreine Co.
Ophthalmic · 167d
Cleared Jun 06, 1988
WAKO(TM) IGG-HA DIRECT
K880784 · DEW
Wako Chemicals USA, Inc.
Immunology · 101d
Cleared Jun 06, 1988
ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY
K880982 · KPR
Orion Corporation Soredex
Radiology · 90d
Cleared Jun 06, 1988
SLT CONTACT LASER SYSTEM OCULOPLASTICS
K881134 · HQF
Surgical Laser Technologies, Inc.
Ophthalmic · 82d
Cleared Jun 06, 1988
IMMUNOGLOBULIN M TEST SYSTEM
K881828 · CFQ
The Binding Site, Ltd.
Immunology · 38d
Cleared Jun 06, 1988
NEW SIZES SUGITA CLIPS
K881911 · HCI
Downs Surgical , Ltd.
Neurology · 28d
Cleared Jun 06, 1988
SANO CLIP APPLIERS & REMOVERS
K881912 · HCI
Downs Surgical , Ltd.
Neurology · 28d
Cleared Jun 06, 1988
REUSABLE FIBEROPTIC LIGHTPIPE
K881926 · HQB
Advanced Surgical Products, Inc.
Ophthalmic · 28d
Cleared Jun 06, 1988
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
K881933 · JZO
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 27d
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