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
135865–135888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1988
ACCUTEK PERIODONTAL PROBE
K880827 · EIX
Sweet Micro Systems, Inc.
Dental · 42d
Cleared Apr 12, 1988
FOLDING HOSPITAL COT NSN 6530-00-299-8517
K881043 · FNJ
Junkin Safety Appliance Co., Inc.
General Hospital · 32d
Cleared Apr 12, 1988
PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES
K881108 · LJG
Sigma Diagnostics, Inc.
Microbiology · 28d
Cleared Apr 12, 1988
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
K881110 · LJG
Sigma Diagnostics, Inc.
Microbiology · 28d
Cleared Apr 12, 1988
ASO SLIDE TEST
K881209 · GTQ
Ncs Diagnostics, Inc.
Microbiology · 22d
Cleared Apr 12, 1988
STRAIGHT LENGTH ARCH WIRES
K881233 · EJF
Flexmedics
Dental · 21d
Cleared Apr 12, 1988
KODAK AUTOMATIC FILM FEEDER, MODEL 11
K881248 · IXW
Eastman Kodak Company
Radiology · 20d
Cleared Apr 12, 1988
CENTER BEND ARCH WIRES
K881274 · EJF
Flexmedics
Dental · 18d
Cleared Apr 12, 1988
HEARING AID (ALL-IN-THE-EAR)
K881296 · ESD
Hearing Aid Co.
Ear, Nose, Throat · 15d
Cleared Apr 11, 1988
VENTI-SCAN II
K871868 · IYT
Atomic Products Corp.
Radiology · 334d
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