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
152521–152544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1984
WESCOTT TYPE BIOPSY NEEDLE
K842406
Popper & Sons, Inc.
General & Plastic Surgery · 51d
Cleared Aug 09, 1984
R.L. MEDICAL TWIN LIGHT SOURCE
K842609 · FCW
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 09, 1984
MICROSTAT GAMMA COUNTER
K842902 · JJJ
Micromedic Systems
Toxicology · 17d
Cleared Aug 09, 1984
SICKLE-HEME A/S HETEROZYGOUS CONTROL
K842955 · GHM
Michclone Associates, Inc.
Hematology · 13d
Cleared Aug 08, 1984
LED STIMULATOR LS-05
K834442 · GWE
Teca, Inc.
Neurology · 236d
Cleared Aug 08, 1984
HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS
K841295 · BTT
Bow/Parm
Anesthesiology · 132d
Cleared Aug 08, 1984
COOPER LASERSONICS, 8000 ND.YAGLASER
K841869 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 96d
Cleared Aug 08, 1984
LIFEMED LIFECOIL CATHETERS
K841929 · FKX
Lifemed of California
Gastroenterology & Urology · 90d
Cleared Aug 08, 1984
VAN-TEC OCCLUSION BALLOON CATHETER
K841941 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 89d
Cleared Aug 08, 1984
EMG MODULE, EMG1, W/OPTIONAL SPEAKER
K842124 · FAP
Endotek Corp.
Gastroenterology & Urology · 71d
Cleared Aug 08, 1984
G.I. CLEANSING KIT
K842130 · FCE
Mmi, Inc.
Gastroenterology & Urology · 70d
Cleared Aug 08, 1984
CORPAK URINARY DRAINAGE BAG
K842257 · KNX
Corpak Co.
Gastroenterology & Urology · 62d
Cleared Aug 08, 1984
ULTRA-VIOLET EMITTING SUNLAMP PRODUCT
K842384 · FTC
Sola-Tan Intl.
Radiology · 51d
Cleared Aug 08, 1984
SUR-FIT NIGHT DRAINAGE CONTAINER SET
K842395 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 50d
Cleared Aug 08, 1984
ACCUSEAL LEG BAGS & EXTENSION TUBES
K842396 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 50d
Cleared Aug 08, 1984
URIHESIVE SYS MALE EXTERNAL CATHETER
K842397 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 50d
Cleared Aug 08, 1984
CLINICOMP R.C.I.
K842540 · KPT
Clinicomp, Inc.
Radiology · 37d
Cleared Aug 08, 1984
CAROLINA X-RAY CO. SIMPLAFLOAT TABLE
K842614 · IXQ
Carolina X-Ray Co., Inc.
Radiology · 34d
Cleared Aug 08, 1984
BIOLAS YAG 100
K842670
Advanced Biomedical Instruments
Cardiovascular · 29d
Cleared Aug 08, 1984
ORTHO ACTIVE KNEE BRACE
K842790
Ortho Active Appliances , Ltd.
Physical Medicine · 9d
Cleared Aug 08, 1984
ORTHO ACTIVE WRIST BRACE
K842791
Ortho Active Appliances , Ltd.
Physical Medicine · 9d
Cleared Aug 08, 1984
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
K842812 · GZJ
Mentor Corp.
Neurology · 21d
Cleared Aug 08, 1984
VACCESS FEMORAL CANNULA
K842864 · KNZ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 16d
Cleared Aug 08, 1984
KNEE-HIP MOBILIZER
K842881 · BXB
Joint Mobilizer Systems, Inc.
Physical Medicine · 16d