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
171217–171240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 31, 1978
NURITE II
K780828 · GZJ
Bio-Medical Systems Corp.
Neurology · 12d
Cleared May 26, 1978
DYNEX BLOOD GAS QUALITY CONTROL SYS.
K780144 · JJS
Analytical Products, Inc.
Chemistry · 122d
Cleared May 26, 1978
SCINTILLATION, LIQUID, RACKBETA
K780341 · JJJ
Lkb Instruments, Inc.
Radiology · 86d
Cleared May 26, 1978
MASSAGER, GUM/SSAGE POWERED GUM
K780360 · JEQ
Sunbeam Corp.
Dental · 81d
Cleared May 26, 1978
TOTAL IRON BINDING CAPACITY
K780412 · JQG
Diagnostic Corp. of America
Chemistry · 72d
Cleared May 26, 1978
ARRHYTHMIA PROGRAM MODULE
K780432 · DSI
Midwest Analog & Digital, Inc.
Cardiovascular · 70d