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
171529–171552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1978
CUTTER RESIFLEX FOLEY CATHETERS
K781140 · DJC
Cutler Laboratories, Inc.
Toxicology · 17d
Cleared Sep 07, 1978
PATIENT AID, MODEL DM-351
K781176 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 57d
Cleared Sep 07, 1978
PULSE GENERATOR MODEL 208
K781178 · DXY
Elema-Schonander, Inc.
Cardiovascular · 59d
Cleared Sep 07, 1978
PENLIGHTS
K781228 · KYT
Abco Dealers, Inc.
General Hospital · 52d
Cleared Sep 07, 1978
GAVAGE ADMIN. SET
K781230 · KNT
Mcgaw Laboratories
Gastroenterology & Urology · 51d
Cleared Sep 07, 1978
MODEL 80100A, PATIENT DATA MEMORY
K781360 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 31d
Cleared Sep 07, 1978
DOBBHOFF ENTERIC FEEDING BAG
K781385 · FPD
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 27d
Cleared Sep 07, 1978
BED PADS: D-12 AND D-8
K781404 · FNM
Grant Airmass Corp.
General Hospital · 28d
Cleared Sep 07, 1978
HYDRON BURN BANDAGE MANUAL APPLICATION
K781406 · KMF
Abbott Laboratories
General & Plastic Surgery · 24d
Cleared Sep 07, 1978
MASK, PXYGEN
K781413 · DPT
Vitalab Products Corp.
Cardiovascular · 23d
Cleared Sep 07, 1978
MASK, OXYGEN, NONBREATHING
K781414 · KGB
Vitalab Products Corp.
Anesthesiology · 23d
Cleared Sep 07, 1978
CANNULA, NASAL, OXYGEN
K781415 · CAT
Vitalab Products Corp.
Anesthesiology · 23d
Cleared Sep 07, 1978
KWIK-FLO URINAL SYSTEM
K781422 · KNX
The Grace Mfg. Co.
Gastroenterology & Urology · 21d
Cleared Sep 07, 1978
CARDIAL PULSE GENERATORS
K781426 · DXY
Telectronics, Inc.
Cardiovascular · 16d
Cleared Sep 07, 1978
ELECTRIC CT/T OPERATOR DISPLAY CONSOLE
K781431 · JAK
General Electric Co.
Radiology · 17d
Cleared Sep 07, 1978
LENSOMETER MODEL 11
K781440 · HLM
Rodenstock Instrument Corp.
Ophthalmic · 20d
Cleared Sep 07, 1978
RADIOEAR RE SERIES HEARING AIDS
K781458 · ESD
Radioear Corp.
Ear, Nose, Throat · 15d
Cleared Sep 07, 1978
U-FLOAT VALVE 2D9023
K781467 · CAF
Travenol Laboratories, S.A.
Anesthesiology · 14d
Cleared Sep 07, 1978
CONTINUOUS FEED VALVE 2D9024
K781468 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 14d
Cleared Sep 07, 1978
MODESS* BELTLESS FEMININE NAPKIN
K781470 · HHD
Personal Products Co.
Obstetrics & Gynecology · 10d
Cleared Sep 07, 1978
PREAMPLIFIER MODELS 8101PI & 8102PI
K781474 · EWO
Life-Tech Instruments, Inc.
Ear, Nose, Throat · 10d
Cleared Sep 07, 1978
ELECTRODE IMPEDANCE TESTER-MODEL 500
K781475 · GYA
Life-Tech Instruments, Inc.
Neurology · 10d
Cleared Sep 01, 1978
BJORK-SHILEY CARDIAC HEART VALVE
K780772
Shiley, Inc.
Cardiovascular · 120d
Cleared Sep 01, 1978
SYSTEM 6000 AUTOMATED RIA ANALYZER
K780886 · LCI
Beckman Instruments, Inc.
Chemistry · 98d