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
124825–124848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1990
ARGENCO 75
K903279 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
ARGENCO 4
K903281 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
ARGENCO 12
K903282 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
ARGENCO IV
K903283 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Aug 13, 1990
DENTALON PLUS
K903317 · EBG
Kulzer, Inc.
Dental · 19d
Cleared Aug 10, 1990
BARNES FEMORAL LENGTHENING DEVICE
K895243 · HRS
Piedmont Sports Medicine &...
Orthopedic · 354d
Cleared Aug 10, 1990
SONOACE 88 PORTABLE ULTRASOUND SCANNER
K900505 · HEM
Medison Co., Ltd.
Obstetrics & Gynecology · 189d
Cleared Aug 10, 1990
ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER
K901335 · DPW
Ge Medical Systems Information...
Cardiovascular · 141d
Cleared Aug 10, 1990
ELASTYREN - EXAMINATION AND DENTAL GLOVES
K901394 · LZA
Danpren Gloves A/S
General Hospital · 137d
Cleared Aug 10, 1990
MULTICATH PLACEMENT KIT
K901640 · FOZ
Vygon Corp.
General Hospital · 123d
Cleared Aug 10, 1990
NEWPORT WAVE VENTILATOR MODEL E200
K901785 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 114d
Cleared Aug 10, 1990
PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15
K901888 · LNH
Medrad, Inc.
Radiology · 106d
Cleared Aug 10, 1990
VPW 2877D5, X-RAY POWER SUPPLY
K902106 · IZO
Varian Assoc., Inc.
Radiology · 94d
Cleared Aug 10, 1990
VISTA - MODELS V12, V20, V23, V38, ITE HEARING AID
K902179 · ESD
Vista Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Aug 10, 1990
MODIFIED SCOOP TRANSTRACHEAL CATHETERS
K902281 · BTO
Transtracheal Systems
Anesthesiology · 80d
Cleared Aug 10, 1990
MODIFIED ASSESS(R) PEAK FLOW METER
K902292 · BZH
Health Products, Inc.
Anesthesiology · 80d
Cleared Aug 10, 1990
DIAGNOSTIC ULTRASOUND UFS 1005
K902408 · EXY
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 71d
Cleared Aug 10, 1990
DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST
K902446 · FMW
Mallinckrodt Group, Inc.
General Hospital · 70d
Cleared Aug 10, 1990
ACS ONE-STAGE PROTHROMBIN TIME REAGENT
K902468 · GJS
Analytical Control Systems, Inc.
Hematology · 67d
Cleared Aug 10, 1990
REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS
K902601 · LYY
Regent Hospital Products
General Hospital · 59d
Cleared Aug 10, 1990
PATIENT EXAMINATION GLOVES
K902617 · LYY
Unicorn Latex, Ltd.
General Hospital · 58d
Cleared Aug 10, 1990
MANAN PROSTATE SEEDING NEEDLE
K902622 · KXK
Manan Medical Products, Inc.
Radiology · 57d
Cleared Aug 10, 1990
FTS-100 FLUID TRANSFER SYSTEM
K902835 · FRN
Richard James, Inc.
General Hospital · 43d
Cleared Aug 10, 1990
IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
K903196 · LLZ
General Electric Co.
Radiology · 22d