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
172153–172176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1978
DENTAL OFFICE ENVIRONMENT CONTROL UNIT
K780701 · EHZ
Laminaire Corp.
Dental · 20d
Cleared May 16, 1978
SPEECH AUDIOMETER RA 226
K780749 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 12d
Cleared May 16, 1978
ENTRAX TRACTION UNIT
K780763 · HSR
Orthopedic Equipment Co., Inc.
Orthopedic · 8d
Cleared May 16, 1978
MICRO RASPS
K780771 · HTR
Amsco Co.
General & Plastic Surgery · 11d
Cleared May 16, 1978
BAGS, PLASTIC, STERILE FOR GENERATORS
K780777 · DXY
Telectronics, Inc.
Cardiovascular · 12d
Cleared May 12, 1978
TOTAL HIP, LORD MADREPORIC
K780330 · KWA
Howmedica Corp.
Orthopedic · 73d
Cleared May 12, 1978
DATA-ZYME TRIGLYCERIDE PROCEDURE
K780379 · CDT
Data Medical Associates, Inc.
Chemistry · 65d
Cleared May 12, 1978
POWER STRIDER
K780402 · ITI
Seidel Manufacturing, Inc.
Physical Medicine · 60d
Cleared May 12, 1978
RELAX-A-TONE
K780436 · HCC
Bio Response
Neurology · 56d
Cleared May 12, 1978
ALT(GPT) UNI-UV, SGPT
K780462 · CKA
Sclavo, Inc.
Chemistry · 50d
Cleared May 12, 1978
AST(GOT) UNI-UV, SGOT
K780463 · CIT
Sclavo, Inc.
Chemistry · 50d
Cleared May 12, 1978
SPECTROPHOTOMETER, ATOMIC ABSORPTION
K780521 · JXR
Instrumentation Laboratory CO
Toxicology · 42d
Cleared May 12, 1978
SPECTROPHOTOMETERS, ATOMIC ABSORPTION
K780522 · JXR
Instrumentation Laboratory CO
Toxicology · 42d
Cleared May 12, 1978
FOME-CUF PVC
K780583 · BTR
Bivona Medical Technologies
Anesthesiology · 30d
Cleared May 12, 1978
HEARING AID BATTERY CHARGER
K780694 · ESD
Cahill Enterprises, Inc.
Ear, Nose, Throat · 18d
Cleared May 12, 1978
STIMULATORS, NERVE, ELECTRICAL
K780698 · GZJ
Med General
Neurology · 16d
Cleared May 12, 1978
COLUMBIA AGAR WITH 5% RABBIT BLOOD
K780704 · JSI
Granite Diagnostics, Inc.
Microbiology · 17d
Cleared May 12, 1978
IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST
K780709
Clinical Assays, Inc.
Toxicology · 16d
Cleared May 12, 1978
CULTURE SWAB
K780713 · JRW
Royal Scientific, Inc.
Microbiology · 15d
Cleared May 12, 1978
CLAMP FORCEPS
K780743 · EJG
Hygienic Dental Mfg., Co., The
Dental · 29d
Cleared May 12, 1978
BRINKER TISSUE RETRACTORS
K780744 · EEF
Hygienic Dental Mfg., Co., The
Dental · 29d
Cleared May 12, 1978
RUBBER DAM
K780745 · EIE
Hygienic Dental Mfg., Co., The
Dental · 29d
Cleared May 12, 1978
HYGIENIC RUBBER DAM FRAME
K780746 · EJE
Hygienic Dental Mfg., Co., The
Dental · 29d
Cleared May 12, 1978
SHORTWAVE DIATHERMY MODEL 802
K780755 · IMJ
Birtcher Corp.
Physical Medicine · 4d