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
163633–163656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1981
LUMAC'S BACTERIURIA SCREENING KIT
K810746 · JXA
Lumac
Toxicology · 134d
Cleared Jul 31, 1981
D-3160 SORBENT CARTRIDGE
K811170 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 94d
Cleared Jul 31, 1981
OPHTHALMIC SCISSORS
K811245 · HNF
Keeler Instruments, Inc.
Ophthalmic · 88d
Cleared Jul 31, 1981
HEMASITE VASCULAR ACCESS SHUNT
K811384 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 73d
Cleared Jul 31, 1981
OECO APNEA MONITOR
K811628 · BZQ
Oeco
Anesthesiology · 52d
Cleared Jul 31, 1981
SOFT & STROKE
K811782 · ISA
Phoenix Intl. Marketing, Inc.
Physical Medicine · 38d
Cleared Jul 31, 1981
FIX-RIGHT 90ML & 180 ML PREFILLED CONT
K811793 · KDT
Richard-Allan Medical Ind., Inc.
Hematology · 37d
Cleared Jul 31, 1981
CLEAR-MOUNT
K811799 · LEB
Richard-Allan Medical Ind., Inc.
Hematology · 37d
Cleared Jul 31, 1981
JAPANESE HOTZIE
K811803 · IMD
Consolidated Health & Sports Prod.
Physical Medicine · 37d
Cleared Jul 31, 1981
TRIANGULAR BANDAGE
K811814 · NAB
Abco Dealers, Inc.
General & Plastic Surgery · 35d
Cleared Jul 31, 1981
SKIN SCRUB KITS
K811855 · KDD
Oem Medical Div.
General & Plastic Surgery · 30d
Cleared Jul 31, 1981
SIGMA PROCEDURE 265-UV
K811864 · CED
Sigma Chemical Co.
Chemistry · 30d
Cleared Jul 31, 1981
VMA PEDIATRIC APNEA MATTRESS
K811865 · BZQ
Vickers America Medical Corp.
Anesthesiology · 30d
Cleared Jul 31, 1981
CORDIS DOW SERA FLO TM TRANSDUCER PROT
K811892 · FIB
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Jul 31, 1981
ARGYLE TARTAN TRACHEAL TUBE
K811937 · BTR
Sherwood Medical Co.
Anesthesiology · 25d
Cleared Jul 31, 1981
AUTONORM & NERV-A-NORM
K811956 · KNM
Autonomic Equipment Supply Co,
Physical Medicine · 22d
Cleared Jul 31, 1981
FORDER RETRACTOR
K811973 · KOA
Surgemed Marketing, Inc.
Gastroenterology & Urology · 21d
Cleared Jul 31, 1981
HEMASITE ACCESS MONITOR (TENT.) #RS-8200
K811977 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 18d
Cleared Jul 31, 1981
VOLUMETRIC INFUSION PUMP
K812021 · FRN
American Edwards Laboratories
General Hospital · 11d
Cleared Jul 31, 1981
ZEE MANUAL RESUSCITATOR
K812022 · BTM
Zee Medical Products Co., Inc.
Anesthesiology · 11d
Cleared Jul 31, 1981
INFUSION PUMP MODEL 200/201
K812042 · FRN
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 10d
Cleared Jul 31, 1981
VANCE CYSTOSCOPIC
K812057 · FBK
Vance Products, Inc.
Gastroenterology & Urology · 10d
Cleared Jul 31, 1981
AKRON URINARY DRAINAGE BAT
K812058 · KNX
Latex Ind., Inc.
Gastroenterology & Urology · 10d
Cleared Jul 30, 1981
VERI-FIER
K811351 · GZJ
Verite
Neurology · 78d