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
134401–134424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 1988
8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS
K862747 · BZQ
Atlas Researches , Ltd.
Anesthesiology · 746d
Cleared Aug 05, 1988
GL-35 COLPOSCOPIC LASER SYSTEM
K875314 · HHR
Laser Engineering, Inc.
Obstetrics & Gynecology · 220d
Cleared Aug 05, 1988
ITE HEARING AID, EAR-TRONICS MODELS: M1-M23
K881299 · ESD
Ear-Tronics, Inc.
Ear, Nose, Throat · 130d
Cleared Aug 05, 1988
SURGEONS GLOVES
K881374 · KGO
Interpro Intl., Inc.
General Hospital · 126d
Cleared Aug 05, 1988
MEDITRON MG-1000 MONOPOLAR GENERATOR
K882049 · GEI
Xylog Corp.
General & Plastic Surgery · 81d
Cleared Aug 05, 1988
LAURIER SANITARY NAPKIN
K882768 · HHD
Kao Corp.
Obstetrics & Gynecology · 30d
Cleared Aug 05, 1988
SCHIFF REAGENT
K883217 · HZT
Surgipath Medical Industries, Inc.
Pathology · 7d
Cleared Aug 04, 1988
EXL-14 MEDICAL LINEAR ACCELERATOR
K880200 · IYE
Mitsubishi Intl. Corp.
Radiology · 206d
Cleared Aug 04, 1988
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K880748 · KNS
Cook Urological, Inc.
Gastroenterology & Urology · 162d
Cleared Aug 04, 1988
BEAR 3 VENTILATOR
K881335 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 128d
Cleared Aug 04, 1988
CAPTIA(R) SYPHILIS-G
K881425 · LIP
Mercia Diagnostics , Ltd.
Microbiology · 121d
Cleared Aug 04, 1988
MERIFLUOR(TM) PNEUMOCYSTIS
K881608 · LYF
Meridian Diagnostics, Inc.
Microbiology · 114d
Cleared Aug 04, 1988
EMERSON CHEST RESPIRATOR, MODEL 33-CRE
K881808 · BYT
J. H. Emerson Co.
Anesthesiology · 98d
Cleared Aug 04, 1988
MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L
K881886 · IZO
U.S. Imaging, Inc.
Radiology · 91d
Cleared Aug 04, 1988
CATHETER, INTRAVASCULAR
K881976 · FOZ
Primrose Medical, Inc.
General Hospital · 85d
Cleared Aug 04, 1988
ETHYL ALCOHOL STANDARD
K882117 · DNN
Verichem Laboratories, Inc.
Toxicology · 77d
Cleared Aug 04, 1988
CLINICAL ELECTRONIC THERMOMETERS
K882127 · FLL
Sheridan Catheter Corp.
General Hospital · 76d
Cleared Aug 04, 1988
TECHNICON DPA-1(TM) SYSTEM
K882153 · DCF
Technicon Instruments Corp.
Immunology · 73d
Cleared Aug 04, 1988
GEMINII GAMMA COUNTER
K882194 · JJE
Laboratory Technologies, Inc.
Toxicology · 71d
Cleared Aug 04, 1988
PHASE II LH KIT
K882252 · CEP
Vitek Systems, Inc.
Chemistry · 65d
Cleared Aug 04, 1988
CORONARY VEIN GRAFT MARKER
K882314 · DSY
Med-Edge, Inc.
Cardiovascular · 62d
Cleared Aug 04, 1988
LASER - 1000
K882436 · EHD
Panoramic Corp.
Radiology · 51d
Cleared Aug 04, 1988
FTI 200 MEDICAL THERMAL IMAGER
K882483 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 49d
Cleared Aug 04, 1988
ALTERNATE PROCEDURE, PHARMACIA IGE EIA
K882616 · JHR
Pharmacia, Inc.
Immunology · 41d