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
127681–127704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1990
TRACHEOSTOMY TRAY
K896798 · BTO
Westmark, Sterile Packing Systems,...
Anesthesiology · 83d
Cleared Feb 22, 1990
HALUX EXLITE MINOR SURGERY LIGHT
K896961 · GBC
Jedmed Instrument Co.
General & Plastic Surgery · 69d
Cleared Feb 22, 1990
CRAGG CONVERTIBLE WIRE
K897152 · DQX
Boston Scientific Corp
Cardiovascular · 58d
Cleared Feb 22, 1990
OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM
K897157 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 58d
Cleared Feb 22, 1990
BIOPOTENTIAL SURFACE ELECTRODE
K900059 · GXY
Integral Design, Inc.
Neurology · 50d
Cleared Feb 22, 1990
VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B
K900115 · CAN
Ventlab Corp.
Anesthesiology · 44d
Cleared Feb 22, 1990
MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
K900237 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 36d
Cleared Feb 22, 1990
MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID
K900238 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 36d
Cleared Feb 22, 1990
ACU-BAND ACCUPRESSURE WRIST BAND
K900588 · MVV
Euro-Am Pharma, Inc.
Neurology · 15d
Cleared Feb 22, 1990
BOOSTER MOTORIZED THREE WHEELED VEHICLE
K900738 · INI
Burke Mobility Products
Physical Medicine · 6d
Cleared Feb 21, 1990
HYDRASORB(TM)
K897156 · NAD
Avitar, Inc.
General & Plastic Surgery · 57d
Cleared Feb 21, 1990
3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
K900108 · DGC
3M Company
Immunology · 43d
Cleared Feb 21, 1990
3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8
K900244 · DGC
3M Company
Immunology · 35d
Cleared Feb 21, 1990
WOODLYN SLIT LAMP MODEL HR-1
K900476 · HJO
Woodlyn, Inc.
Ophthalmic · 20d
Cleared Feb 21, 1990
WOODLYN CLASSIC SLIT LAMP MODEL SMM
K900477 · HJO
Woodlyn, Inc.
Ophthalmic · 20d
Cleared Feb 21, 1990
WOODLYN FULL APERTURE TRIAL LENS SET
K900478 · HPC
Woodlyn, Inc.
Ophthalmic · 20d
Cleared Feb 20, 1990
EMS 8100
K895301 · IPF
Henley Intl.
Physical Medicine · 179d
Cleared Feb 20, 1990
SORBEX(TM) SOFT SPONGE
K895654 · NAD
Fountain Pharmaceuticals, Inc.
General & Plastic Surgery · 153d
Cleared Feb 20, 1990
ULTRA (THERAPEUTIC ULTRASOUND DEVICE)
K895690 · IMG
Excel Tech. , Ltd.
Physical Medicine · 151d
Cleared Feb 20, 1990
MULTISTIM PLUS
K895983 · IPF
Excel Tech. , Ltd.
Physical Medicine · 148d
Cleared Feb 20, 1990
4 SURE URINARY DRAIN BAG
K896727 · KNX
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 83d
Cleared Feb 20, 1990
4 SURE URINARY LEG BAG
K896728 · FAQ
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 83d
Cleared Feb 20, 1990
TOI-LIFT
K896814 · INN
Mill-Tech Ent., Inc.
Physical Medicine · 78d
Cleared Feb 20, 1990
EXCEL STIM
K896836 · IPF
Excel Tech. , Ltd.
Physical Medicine · 99d