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
173809–173832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1977
KARAYA GUM POWDER
K770230 · EZR
Atlantic Surgical
Gastroenterology & Urology · 21d
Cleared Feb 28, 1977
SUPER X ADJUSTRETTE
K770251 · EXD
Qualitone
Gastroenterology & Urology · 19d
Cleared Feb 28, 1977
SYS. FOR REC. BSER RESPONSES
K770268 · GWJ
Life-Tech Instruments, Inc.
Neurology · 17d
Cleared Feb 28, 1977
HEARING AID, DM IROS DIRECTIONAL
K770308 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 12d
Cleared Feb 28, 1977
HEARING AID, DM IROS
K770309 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 12d
Cleared Feb 28, 1977
PERCEPTOR
K770321 · ESD
Danavox, Inc.
Ear, Nose, Throat · 11d
Cleared Feb 28, 1977
VERI/TRODES
K770323 · GXY
Verite Scientific, Inc.
Neurology · 11d
Cleared Feb 28, 1977
PACEMAKER, ANTRIO-VENTRICULAR SEQ.
K770328 · DXY
American Pacemaker Corp.
Cardiovascular · 11d
Cleared Feb 28, 1977
COLLIMATOR, AUTOMATIC
K770335 · KPW
Litton Medical Systems
Radiology · 10d
Cleared Feb 28, 1977
BANDAGE, PLASTIC & SHEER
K770339 · FPX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 10d
Cleared Feb 28, 1977
BANDAGES, PLASTER OF PARIS & SPLINTS
K770340 · ITG
Johnson & Johnson Professionals, Inc.
Physical Medicine · 10d
Cleared Feb 28, 1977
TEMP. PROBE, & ELECTRONIC THERMOMETER
K770341 · DRF
Electro-Catheter Corp.
Cardiovascular · 10d
Cleared Feb 28, 1977
MAXICAMERA II
K770343 · IYX
General Electric Co.
Radiology · 10d
Cleared Feb 28, 1977
HEARING AID, MAICO DM MARK 180
K770360 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 6d
Cleared Feb 25, 1977
GLOVES, SURGEONS,MICRO-TOUCH POWDERFREE
K770056 · KGO
Arbrook Mfg. Corp.
General Hospital · 45d
Cleared Feb 25, 1977
EPIDURAL BLOCK PROCEDURE PACK
K770096 · CAZ
American Viggo
Anesthesiology · 39d
Cleared Feb 25, 1977
MAJOR SUTURE REMOVAL TRAY
K770149 · KDD
Pharmaseal Div., Baxter Healthcare Corp.
General & Plastic Surgery · 32d
Cleared Feb 25, 1977
SAUVAGE FILAMENTOUS PROSTHESES
K770236 · DSY
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 18d
Cleared Feb 25, 1977
LC-65T DETECTOR AND OVEN
K770255 · KZR
The Perkin-Elmer Corp.
Toxicology · 15d
Cleared Feb 25, 1977
HOOD & BEARD COVER, CLARION SURGEON'S
K770257 · FXY
Sherwood Medical Industries
General Hospital · 14d
Cleared Feb 25, 1977
CHOLESTEROL TEST
K770265 · CHH
Sclavo, Inc.
Chemistry · 14d
Cleared Feb 25, 1977
VENTILATOR BREATHING CIRCUIT
K770286 · CAI
Mcgaw Respiratory Therapy
Anesthesiology · 11d
Cleared Feb 24, 1977
ANAL/RECTAL SYRINGE
K761229 · KOA
Ace Orthopedic Manufacturing Co.
Gastroenterology & Urology · 76d
Cleared Feb 24, 1977
BAND-AGE ICE-BANDAGE
K761254 · ILO
Surgicot, Inc.
Physical Medicine · 73d