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

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176,076 results
172057–172080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1978
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · CDP
Bd Becton Dickinson Vacutainer...
Chemistry · 25d
Cleared Jun 06, 1978
GAUZE SPONGES
K780795 · NAB
Abco Dealers, Inc.
General & Plastic Surgery · 22d
Cleared Jun 06, 1978
ELECTRONIC THERMOMETER
K780800 · FLL
Metek Corp.
General Hospital · 22d
Cleared Jun 06, 1978
TILL-U-TEST, DIP SLIDE
K780803 · JXA
Biotron , Ltd.
Microbiology · 26d
Cleared Jun 06, 1978
S/D 600 SPHYGMOMANOMETER AND PULSEMETER
K780805 · DXN
G & W Applied Science Laboratories
Cardiovascular · 26d
Cleared Jun 02, 1978
VOLUME CONTROL DEVICE VCD-150
K780465 · KZD
Sorensen Research
Hematology · 72d
Cleared Jun 02, 1978
GASTRIC LAVAGE KIT
K780471 · FAT
Gaymar Industries, Inc.
Gastroenterology & Urology · 70d
Cleared Jun 02, 1978
EAR ELECTRODE-ADULT & PEDIATRIC
K780537 · GXY
Life-Tech Instruments, Inc.
Neurology · 60d
Cleared Jun 02, 1978
ENEMA, PHOSPHATE
K780613 · FCE
Abco Dealers, Inc.
Gastroenterology & Urology · 53d
Cleared Jun 02, 1978
BUBBLE SUCTION TUBING
K780724 · BYY
Davol, Inc.
General Hospital · 30d
Cleared Jun 02, 1978
CT 5221 DOSE REDUCING COLLIMATORS
K780736 · IZX
Emi Medical, Inc.
Radiology · 32d
Cleared Jun 02, 1978
CT BLANKETS (BOLUS MATERIAL)
K780737 · JAK
Emi Medical, Inc.
Radiology · 32d
Cleared Jun 02, 1978
S-100 CT SCANNER
K780769 · JAK
Syntex Corp.
Radiology · 28d
Cleared Jun 02, 1978
HBF-QUIPLATE METHODOLOGY
K780807 · JBD
Helena Laboratories
Hematology · 29d
Cleared Jun 02, 1978
PREVI DENT PROPHYLAXIS MINT NDC
K780834 · EJR
Hoyt Laboratories
Dental · 9d
Cleared Jun 02, 1978
GAMMA CAMERA
K780855 · IYX
G.D. Searle and Co.
Radiology · 14d
Cleared May 31, 1978
OUTPUT DIGITAL DISPLAY MODULE, MODEL 401
K780356 · DSK
Output, Inc.
Cardiovascular · 86d
Cleared May 31, 1978
INSTRUMENT LUBRICANT
K780610
Abco Dealers, Inc.
General & Plastic Surgery · 51d
Cleared May 31, 1978
CONTROLLER, SERVO, INSPIRON
K780630 · BZE
C.R. Bard, Inc.
Anesthesiology · 44d
Cleared May 31, 1978
MODIFIED UNTREATED TAMPAX TAMPONS
K780648 · HEB
Tampax, Inc.
Obstetrics & Gynecology · 44d
Cleared May 31, 1978
RTV SILICONE HAND KNEADABLE PUTTY
K780778 · ELW
Crown Delta Corp.
Dental · 20d
Cleared May 31, 1978
HEARING AID MODEL 8148
K780820 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 12d
Cleared May 31, 1978
HEARING AID MODEL 8160H
K780821 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 12d
Cleared May 31, 1978
HEARING AID MODEL 8160U
K780822 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 12d