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
105697–105720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1994
VERDICT COCAINE
K943710 · DIO
Editek, Inc.
Chemistry · 108d
Cleared Nov 17, 1994
VERDICT OPIATES
K943712 · DJG
Editek, Inc.
Toxicology · 108d
Cleared Nov 17, 1994
LENSCHEK
K944022 · HLM
Leica, Inc.
Ophthalmic · 92d
Cleared Nov 17, 1994
POWDER FREE SURGEON'S GLOVE
K944054 · KGD
Arent Fox
Gastroenterology & Urology · 90d
Cleared Nov 17, 1994
ISOSCAN
K944185 · JQT
Isolab, Inc.
Chemistry · 83d
Cleared Nov 17, 1994
SERUM PROTEIN CONTROLS
K944515 · JJX
Pyramid Biological Corp.
Chemistry · 63d
Cleared Nov 17, 1994
LATEX EXAMINATION GLOVES
K944778 · OPE
Pt. Haloni Jane
General & Plastic Surgery · 51d
Cleared Nov 17, 1994
ALLROUND 4
K944889 · EJT
J.F. Jelenko & Co., Inc.
Dental · 44d
Cleared Nov 17, 1994
SAS QUANT HCG URINE
K944891 · JJX
Sa Scientific, Inc.
Chemistry · 44d
Cleared Nov 17, 1994
FREE-LANCE
K944948 · FMK
F.F.F. Enterprises, Inc.
General & Plastic Surgery · 41d
Cleared Nov 17, 1994
MULTIDEX HYDROPHILIC WOUND DRESSING
K945000 · KMF
Lange Medical Products, Inc.
General & Plastic Surgery · 35d
Cleared Nov 16, 1994
ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES
K935246 · DRX
Arbo Medical, Inc.
Cardiovascular · 380d
Cleared Nov 16, 1994
FILTER, DIFFUSER
K940276 · HSZ
Anspach Mfg., Inc.
Orthopedic · 299d
Cleared Nov 16, 1994
AIRWATCH MONITOR
K941226 · BZH
Enact Health Management Systems
Anesthesiology · 247d
Cleared Nov 16, 1994
DESENTECH PLUME-EVAC SMOKE EVACUATION SYSTEM
K944030 · GEI
Desentech, Inc.
General & Plastic Surgery · 91d
Cleared Nov 16, 1994
NEEDLELESS URINE SAMPLING PORT
K944236 · KNX
Kendall Healthcare Products Co....
Gastroenterology & Urology · 76d
Cleared Nov 16, 1994
MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID
K944241 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 77d
Cleared Nov 16, 1994
KARL STORZ MONOPOLAR HIGH FREQUENCY CORDS
K945380 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 14d
Cleared Nov 15, 1994
ELMED LBC 50-P
K926517 · HIN
Elmed, Inc.
Obstetrics & Gynecology · 685d
Cleared Nov 15, 1994
DAVOL ATS
K931899 · CAC
Davol, Inc.
Anesthesiology · 575d
Cleared Nov 15, 1994
PAPER FILM
K940664 · LLZ
Astro Office Products, Inc.
Radiology · 270d
Cleared Nov 15, 1994
DANAVOX MODEL CIC
K942331 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 183d
Cleared Nov 15, 1994
ANGIOTENSIN CONVERTING ENZYME REA
K942497 · KQN
American Laboratory Products Co., Ltd.
Chemistry · 182d
Cleared Nov 15, 1994
EMIT 2000 DIGOXIN ASSAY
K943500 · KXT
Syva Co.
Toxicology · 133d