Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
172969–172992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1977
AUTOMATIC ANALYZER
K771662 · JJC
Lachat Chemicals, Inc.
Chemistry · 98d
Cleared Dec 06, 1977
LIPASE
K771903 · CDT
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
GLYCEROL KINASE
K771904 · CDT
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
GLYCEROL SUBSTRATE
K771905 · CDT
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
PHOSPHATE
K771906 · CDT
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
MICROBIOLOGICAL CULTURE MEDIUM
K771936 · JSH
Scott Laboratories, Inc.
Microbiology · 50d
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