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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
150889–150912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1984
ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)
K844141 · KHW
Lmd Laboratories
Microbiology · 44d
Cleared Dec 05, 1984
COULTER COUNTER MODEL M4
K843303 · GKL
Coulter Electronics, Inc.
Hematology · 104d
Cleared Dec 05, 1984
COLOSCREEN SELF-TEST
K843352 · KHE
Helena Laboratories
Hematology · 100d
Cleared Dec 05, 1984
PHARMA-PLAST RECTAL TIP
K843477 · FCF
Zimmar Consulting , Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 05, 1984
PHARMA-PLAST URIDROP-URIDOME
K843478 · KNX
Zimmar Consulting , Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 05, 1984
INTRAVENOUS START KIT
K843813
Pro-Lab, Inc.
General & Plastic Surgery · 68d
Cleared Dec 05, 1984
PERCUTANEOUS NEPHROSTOMY TROCAR SYS
K844090 · LJE
American Edwards Laboratories
Gastroenterology & Urology · 44d
Cleared Dec 05, 1984
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR
K844222 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 34d
Cleared Dec 05, 1984
OPHTHALMIC STAND
K844363 · HMF
Luneau Laboratories
Ophthalmic · 22d
Cleared Dec 05, 1984
PMS DRAPE PACK
K844465 · KKX
Professional Medical Services
General Hospital · 16d
Cleared Dec 05, 1984
QUANTUM 412
K844570 · HPT
Keta Corp.
Ophthalmic · 12d
Cleared Dec 04, 1984
ARM-A-FLOW INTRAVENOUS FLOW REGULATOR
K842209 · LDR
Armour Pharmaceutical Co.
General Hospital · 183d
Cleared Dec 04, 1984
DRESSING CHANGE TRAY STERILE 5002
K842404
Pro-Lab, Inc.
General & Plastic Surgery · 168d
Cleared Dec 04, 1984
SHAVE PREP KITS
K842989 · KME
Biological & Environmental Control...
General Hospital · 127d
Cleared Dec 04, 1984
ELASTIC BANDAGE
K843056 · GAX
Sterile Medical Systems
General & Plastic Surgery · 123d
Cleared Dec 04, 1984
UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM
K843090 · FPA
Geneva Laboratories, Inc.
General Hospital · 120d
Cleared Dec 04, 1984
MINUTEMAN CO2 MICROSURGICAL LASER OTO
K843514 · EWG
American Surgical Laser, Inc.
Ear, Nose, Throat · 90d
Cleared Dec 04, 1984
VENESECTION TRAY, ADULT 6050
K843627 · FSM
Pro-Lab, Inc.
General & Plastic Surgery · 81d
Cleared Dec 04, 1984
RESPIRATION & HEART RATE MONITOR 530
K843681 · BZQ
Tri-Med, Inc.
Anesthesiology · 77d
Cleared Dec 04, 1984
BIOSELF TM 110
K843699 · LHD
Bioself, Inc.
Obstetrics & Gynecology · 75d
Cleared Dec 04, 1984
CAB2 COMPUTER ASSISTED BIOFEEDBACK
K843738 · HCC
Discrete Data Systems, Inc.
Neurology · 70d
Cleared Dec 04, 1984
TRANSLUX CL
K843823 · EBZ
Kulzer, Inc.
Dental · 67d
Cleared Dec 04, 1984
HE TEST
K843843 · BSE
Erich Jaeger, Inc.
Anesthesiology · 64d
Cleared Dec 04, 1984
RESPIRONICS SLEEPEASY NASAL CPAP SYS
K843889 · BYE
Respironics, Inc.
Anesthesiology · 63d