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
166897–166920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1980
CCD ENDOSCOPE AND ATTACHMENTS
K801247 · GCP
Welch Allyn, Inc.
Gastroenterology & Urology · 61d
Cleared Jul 28, 1980
MAGILL CATHETER INTRO. FORCEPS
K801273 · KOA
J. Sklar Mfg. Co., Inc.
Gastroenterology & Urology · 60d
Cleared Jul 28, 1980
YSI MODELS 23C & 23CM HDL & TOTAL CHOLES
K801285 · CHH
Yellow Springs Instrument Co., Inc.
Chemistry · 60d
Cleared Jul 28, 1980
MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST
K801303 · KDI
Western Laboratories Corp.
Gastroenterology & Urology · 55d
Cleared Jul 28, 1980
MODEL 900K PHOTOCOAGULATOR
K801336 · HQF
Coherent Medical Division
Ophthalmic · 54d
Cleared Jul 28, 1980
EPILATOR, MODEL CP-16
K801351 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 49d
Cleared Jul 28, 1980
PRUITT VASCULAR SHUNT
K801359 · DWF
Ideas For Medicine, Inc.
Cardiovascular · 49d
Cleared Jul 28, 1980
DISPOSABLE TEMPERATURE PROBE COVER
K801366 · FLL
Bib, Inc.
General Hospital · 48d
Cleared Jul 28, 1980
FITE FIXATION TOY FOR OCULAR EXAM
K801381 · HPL
Fite Engineering Corp.
Ophthalmic · 47d
Cleared Jul 28, 1980
OH-HARRIS
K801388 · KIH
Johnson & Johnson Professionals, Inc.
Orthopedic · 45d
Cleared Jul 28, 1980
BARO/TRAC II & VITA/TRAC, VITAL SIGN MON
K801389 · DXN
Bib, Inc.
Cardiovascular · 45d
Cleared Jul 28, 1980
MARK III ULTRASONIC SCANNING SYSTEM
K801406 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 42d
Cleared Jul 28, 1980
SYNERVIEW MODEL 6545
K801407 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 42d
Cleared Jul 28, 1980
CINESCOPE III
K801408 · IZO
Philips Medical Systems (Cleveland),...
Radiology · 42d
Cleared Jul 28, 1980
TUBE HOLDER
K801421 · LDQ
Devon Industries, Inc.
General & Plastic Surgery · 41d
Cleared Jul 28, 1980
TISSUE-TEK III MICROJECT DISP. BLADE SYS
K801426 · IDL
Miles Laboratories, Inc.
Pathology · 41d
Cleared Jul 28, 1980
TISSUE-TEK III MINI-RAPID PROCESSOR
K801427 · IEO
Miles Laboratories, Inc.
Pathology · 41d
Cleared Jul 28, 1980
SUNSATION
K801429 · LEJ
Fashion, Inc.
Radiology · 41d
Cleared Jul 28, 1980
CENTRIFICHEM SYSTEM MANAGER
K801438 · JQP
Union Carbide Corp.
Chemistry · 39d
Cleared Jul 28, 1980
PFIZER PZ-CT SCANNER
K801446 · JAK
Pfizer Medical Systems, Inc.
Radiology · 38d
Cleared Jul 28, 1980
WINTER HEAD DRESSING
K801458 · FQM
Steridyne Corp.
General Hospital · 34d
Cleared Jul 28, 1980
PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT
K801460 · GGW
Pacific Hemostasis
Hematology · 34d
Cleared Jul 28, 1980
THERMA-SHIELD
K801461 · FMZ
Olympic Medical Corp.
General Hospital · 34d
Cleared Jul 28, 1980
SPOR-O-THERM
K801462 · JTQ
Mdt Corp., Inc.
Microbiology · 34d