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
172129–172152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1977
AMES T-3 UPTAKE STRIP TEST
K772088 · KHQ
Miles Laboratories, Inc.
Immunology · 32d
Cleared Dec 06, 1977
PH CALIBRATION BUFFERS
K772106 · JIT
General Diagnostics
Chemistry · 29d
Cleared Dec 06, 1977
IN VITRO HUMAN TSH RIA TEST
K772109 · JLW
Clinical Assays, Inc.
Immunology · 29d
Cleared Dec 06, 1977
ULTRACHEM TOTAL PROTEIN, #64974
K772155 · CEK
Harleco
Chemistry · 20d
Cleared Dec 06, 1977
ULTRACHEM PHOSPHORUS, 64973
K772156 · CEO
Harleco
Chemistry · 20d
Cleared Dec 06, 1977
CREATININE, 64972
K772157 · CGX
Harleco
Chemistry · 20d
Cleared Dec 06, 1977
DYNAZYME TM II CARDIAK-MB
K772172 · JHW
J.T. Baker Chemical Co.
Chemistry · 15d
Cleared Dec 05, 1977
SCANNING SYS., AUTO. COMP., ACS1000
K772140 · JOY
Honeywell, Inc.
Hematology · 21d
Cleared Dec 05, 1977
CT SCANNER DIAGNOSTIC CONSOLE, REMOTE
K772198 · JAK
Varian Assoc., Inc.
Radiology · 6d
Cleared Dec 02, 1977
J-VAC VACUUM TUBE
K771874 · GIM
Jelco Laboratories
Hematology · 60d
Cleared Dec 02, 1977
PANORAMIC X-RAY SYSTEM MODEL A
K772164 · EHD
Sybron Corp.
Radiology · 15d
Cleared Dec 02, 1977
AUDIOMETER, RECORDING, AUTOMATIC
K772169 · EWO
B&K Instruments, Inc.
Ear, Nose, Throat · 14d
Cleared Dec 02, 1977
NASSAL PRESSURE/FLOW RECORDER
K772193 · ETL
Adco Labs.
Ear, Nose, Throat · 4d
Cleared Nov 30, 1977
TOTAL KNEE PROSTHESIS-NONCONSTRAINED
K771511 · HSX
3M Company
Orthopedic · 114d
Cleared Nov 30, 1977
IOPSY TRAY FOR SOFT TISSUE BIOPSY
K771784 · GAA
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 68d
Cleared Nov 30, 1977
ULTRAFILTRATION MONITOR 5M9034
K771875 · FIL
Travenol Laboratories, S.A.
Hematology · 56d
Cleared Nov 30, 1977
OMNIMEDICAL 400L
K771990 · JAK
Omnimedical Services, Inc.
Radiology · 42d
Cleared Nov 30, 1977
PLATELET KIT
K772105 · GLG
Streck Laboratories, Inc.
Hematology · 23d
Cleared Nov 30, 1977
FIAX C4 ASSAY
K772114 · DAK
Idt, A Division of Whittaker M.A....
Immunology · 23d
Cleared Nov 30, 1977
URINARY VMA - SCREEN TEST KIT
K772151 · CDF
Eppendorf-Brinkmann, Inc.
Chemistry · 15d
Cleared Nov 30, 1977
CERVICAL TRACTION DIV., PNEUMATIC
K772154 · ITH
Jobst
Physical Medicine · 16d
Cleared Nov 30, 1977
MOLDEYE
K772168 · HQN
Robert B. Scott Ocularists of...
Ophthalmic · 22d
Cleared Nov 30, 1977
LAPAROSCOPE W/REMOVABLE OPTICS
K772185 · HET
Kli
Obstetrics & Gynecology · 5d
Cleared Nov 29, 1977
CATHETER, UMBILICAR ARTERY
K771022 · FOS
Axiom Medical, Inc.
General Hospital · 176d