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
170593–170616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1978
TECHNICON STAT/LYTE ISE ELECTROLYTE
K781503 · JJC
Technicon Instruments Corp.
Chemistry · 28d
Cleared Sep 27, 1978
TEST SYSTEM TISSUE CELL CULTURE SLIDE
K781516 · KIY
Zeus Scientific, Inc.
Pathology · 27d
Cleared Sep 27, 1978
COULTER ELECTROLYTE ANALYZER SYSTEM
K781528 · JJE
Coulter Electronics, Inc.
Chemistry · 22d
Cleared Sep 27, 1978
PLASTI-PORE SEPTAL BUTTON
K781574 · FZE
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 9d
Cleared Sep 27, 1978
DISPOSABLE CARDIOTOMY
K781577 · DTN
C.R. Bard, Inc.
Cardiovascular · 12d
Cleared Sep 27, 1978
BODY-WORN HEARING AID, MODEL 787PP
K781595 · ESD
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 27, 1978
HEARING AID, MODEL 775 PP/AGC
K781596 · ESD
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 27, 1978
PM 2000 AUTOMATIC PATIENT CHAIR
K781597 · FFG
Time Motion System Co.
Gastroenterology & Urology · 12d
Cleared Sep 27, 1978
CENTRAL PEG TIBIAL COMPONENT
K781608 · HRY
Howmedica Corp.
Orthopedic · 9d
Cleared Sep 26, 1978
DLC 500, DOUBLE LUMEN CATHETER
K781050 · KOC
Hemodialysis, Division of The
Gastroenterology & Urology · 97d
Cleared Sep 26, 1978
MUSCLE STIMULATOR, ELECTRICAL
K781113 · IPF
Rich-Mar Corp.
Physical Medicine · 85d
Cleared Sep 26, 1978
MUSCLE STIMULATOR, ELECTRONIC
K781139 · IPF
Thor Medical Instruments, Inc.
Physical Medicine · 82d
Cleared Sep 26, 1978
ELECTRODE, DEIP.
K781163 · DRX
Datascope Corp.
Cardiovascular · 76d
Cleared Sep 26, 1978
MODEL 80032A, OBSTETRICAL TELEMETRY
K781359 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 50d
Cleared Sep 26, 1978
WATERPATH SCANNING OPTION
K781508 · IYO
G.D. Searle and Co.
Radiology · 25d
Cleared Sep 26, 1978
ZEE-FRAME
K781509 · JAY
Equilibrated Bio Systems, Inc.
Anesthesiology · 25d
Cleared Sep 26, 1978
FLOMETER
K781541 · CAX
Chemetron Medical Products, Inc.
Anesthesiology · 18d
Cleared Sep 20, 1978
CONNECTING TUBE, CONDUCTIVE, SURG.
K781127 · GAZ
Seamless Hospital Products Co.
General Hospital · 77d
Cleared Sep 20, 1978
STIMULATOR, NERVE, TRANSCUTANEOUS
K781157
Medtech Intl., Inc.
Neurology · 77d
Cleared Sep 20, 1978
MERCURY DISP. CAPSULE
K781243 · DZS
Lee Pharmaceuticals
Dental · 100d
Cleared Sep 20, 1978
LUNG EXER. BAG, POST-OP, MODIFIED
K781245 · BWF
Dytek Corp.
Anesthesiology · 65d
Cleared Sep 20, 1978
DIGITAL PANEL METER
K781255 · DRT
Rae Medical Corp.
Cardiovascular · 61d
Cleared Sep 20, 1978
CATHODE RAY TUBE MED. DISPLAY
K781256 · DXJ
Rae Medical Corp.
Cardiovascular · 61d
Cleared Sep 20, 1978
PAB CONVENIENCE TRAY
K781264 · GAA
Waters Assoc., Inc.
General & Plastic Surgery · 58d