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
125425–125448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 10, 1990
SPECIAL RONGEUR
K903401 · HAE
Sur-Med Instruments, Inc.
Neurology · 10d
Cleared Aug 10, 1990
JACE MODEL 100 KNEE CPM DEVICE
K903467 · BXB
Thera Kinetics, Inc.
Physical Medicine · 9d
Cleared Aug 09, 1990
D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)
K895687 · KCW
Carol Block, Ltd.
General & Plastic Surgery · 321d
Cleared Aug 09, 1990
CHIBA SPINAL SYSTEM
K895978 · KWP
Danek Medical, Inc.
Orthopedic · 301d
Cleared Aug 09, 1990
CAS (COMPUTERIZED ANALYZER SYSTEM)
K896996 · ETW
Gn Danavox, Inc.
Ear, Nose, Throat · 241d
Cleared Aug 09, 1990
SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT
K896999 · IYO
Shimadzu Corp.
Radiology · 239d
Cleared Aug 09, 1990
PERTAC-HYBRID
K900510 · EBF
Espe GmbH (Us)
Dental · 188d
Cleared Aug 09, 1990
MODIFIED BIVONA EPISTAXIS CATHETER
K900583 · EMX
Bivona Medical Technologies
Ear, Nose, Throat · 183d
Cleared Aug 09, 1990
VACUTAINER PLUS WITH HEMOGARD CLOSURE
K901449 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 134d
Cleared Aug 09, 1990
CE-8 CUSTOM IN-THE-EAR HEARING AIDS
K901833 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 107d