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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
84841–84864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1999
SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
K991273 · MQE
Swemed Lab International AB
Obstetrics & Gynecology · 127d
Cleared Aug 18, 1999
DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
K991283 · DZE
Micro Motors, Inc.
Dental · 125d
Cleared Aug 18, 1999
BIPOLAR SHOULDER PROSTHESIS
K991585 · KWT
Biomet, Inc.
Orthopedic · 103d
Cleared Aug 18, 1999
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
K991719 · CAZ
Medimex Holfeld GmbH & Co.
Anesthesiology · 90d
Cleared Aug 18, 1999
CUTANEOUS (BAR) ELECTRODE
K991769 · GXY
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
CUTANEOUS (GROUND) ELECTRODE
K991770 · GXY
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
DIGITAL RING ELECTRDE
K991771 · GXY
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
CUTANEOUS (DISC) ELECTRODE
K991772 · GXY
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
K-L-W INTRAORAL DISTRACTOR
K991875 · MQN
KLS-Martin L.P.
Dental · 77d
Cleared Aug 18, 1999
KSEA CALCUSPLIT
K992114 · FFK
Karl Storz Endoscopy
Gastroenterology & Urology · 57d
Cleared Aug 18, 1999
PRODIGY 4 TRANSLUCENT SHADES
K992118 · EBF
Sybron Dental Specialties, Inc.
Dental · 56d
Cleared Aug 18, 1999
NEXUS 2
K992160 · EMA
Sybron Dental Specialties, Inc.
Dental · 54d
Cleared Aug 18, 1999
DUTECK DIGITAL CLINICAL THERMOMETER
K992327 · FLL
Duteck Industrial Co., Ltd.
General Hospital · 37d
Cleared Aug 18, 1999
UROSURGE SPIRALFLO URETERAL STENT
K992391 · FAD
Urosurge, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 18, 1999
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
K992411 · DRT
Medical Data Electronics
Cardiovascular · 29d
Cleared Aug 18, 1999
DAILIES (NELFILCON A) ONE-DAY
K992446 · MVN
Ciba Vision Johns Creek Mfg.
Ophthalmic · 27d
Cleared Aug 18, 1999
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT...
K992500 · LPL
Cantor & Silver , Ltd.
Ophthalmic · 23d
Cleared Aug 17, 1999
KONICA DIRECT DIGITIZER, MODEL DD-341
K990359 · MQB
Konica Corp.
Radiology · 193d
Cleared Aug 17, 1999
TWO RIVERS POWER LIFT/RECLINE CHAIR
K991693 · INO
Two Rivers, LLC
Physical Medicine · 91d
Cleared Aug 17, 1999
MAXIM REMOVABLE MOLDED POLY TIBIA
K991753 · JWH
Biomet, Inc.
Orthopedic · 85d
Cleared Aug 17, 1999
SOMATOM PROJECT 10-CT SCANNERS
K991764 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Aug 17, 1999
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR...
K991785 · BTL
Instrumentation Industries, Inc.
Anesthesiology · 84d
Cleared Aug 17, 1999
KMI WRIST FUSION SYSTEM
K991873 · HRS
Kinetikos Medical, Inc.
Orthopedic · 76d
Cleared Aug 17, 1999
MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD...
K991980 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 64d