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
136465–136488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 1988
TRACHEAL TUBE LASER SHIELD KIT
K874679 · BTR
Americal Corp.
Anesthesiology · 150d
Cleared Apr 11, 1988
HUESTIS COMPU-FORMER
K880047 · IXI
Huestis Machine Corp.
Radiology · 96d
Cleared Apr 11, 1988
RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100
K880092 · BXB
Invacare Corp.
Physical Medicine · 90d
Cleared Apr 11, 1988
MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
K880171 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 87d
Cleared Apr 11, 1988
MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS
K880326 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 76d
Cleared Apr 11, 1988
KING OF HEARTS
K880626 · DXH
Instromedix, Inc.
Cardiovascular · 55d
Cleared Apr 11, 1988
BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
K880637 · BZO
Baxter Healthcare Corp
Anesthesiology · 55d
Cleared Apr 11, 1988
REVERSE CURVE ARCHWIRE
K880882 · EJF
Flexmedics
Dental · 39d
Cleared Apr 11, 1988
STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES
K880969 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Apr 11, 1988
SCHULDT* PC* - DUAL CHANNEL TENS
K880980 · GZJ
Schuldt Laboratories, Inc.
Neurology · 34d
Cleared Apr 11, 1988
SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE
K881085 · DRX
Contour Electrodes, Inc.
Cardiovascular · 34d
Cleared Apr 11, 1988
STERILE ESMARCH BANDAGE
K881176 · GAX
Spectrum/Hydro-Med Products, Inc.
General & Plastic Surgery · 24d
Cleared Apr 11, 1988
3 FRENCH FLEXIBLE BIOPSY FORCEPS
K881399 · OCZ
Cook Urological, Inc.
Gastroenterology & Urology · 7d
Cleared Apr 11, 1988
PREMIER 10S (TENS)
K881424 · GZJ
American Imex
Neurology · 6d
Cleared Apr 08, 1988
ELITE MODULAR HIP SYSTEM
K871867 · JDI
Thackray USA
Orthopedic · 331d
Cleared Apr 08, 1988
MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR
K874137 · FKT
Ash Medical Systems, Inc.
Gastroenterology & Urology · 178d
Cleared Apr 08, 1988
INTELECT MODEL 120
K880235 · IPF
Chattanooga Group, Inc.
Physical Medicine · 79d
Cleared Apr 08, 1988
ARCHGAUGE(TM)
K881024 · IPF
Archxerciser Corp.
Physical Medicine · 29d
Cleared Apr 08, 1988
YESNG PATIENT PLATE #80226
K881144 · JOS
Ferguson Medical
General & Plastic Surgery · 22d
Cleared Apr 08, 1988
ENDICOTT & BEAMAN SUPRA-TEC FACE MASK
K881372 · FXX
Endicott & Beaman, Inc.
General Hospital · 7d
Cleared Apr 08, 1988
NON-STERILE SUTURE NEEDLES
K881394 · GDL
China National Medicines C/O Havel'S
General & Plastic Surgery · 4d
Cleared Apr 07, 1988
SIM 4000I
K873845 · IYO
Ote-Biomedica Elettronica S.P.A
Radiology · 198d
Cleared Apr 07, 1988
IVT CENTRAL ALLERGY SCREEN
K875329 · DHB
In Vitro Technologies, Inc.
Immunology · 99d
Cleared Apr 07, 1988
AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)
K875346 · GKZ
Contraves Medical Instruments, Inc.
Hematology · 98d