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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
143689–143712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1986
STYLEKEEPER CONTACT LENS CARRYING CASE
K861643 · HPX
Allergan, Inc.
Ophthalmic · 33d
Cleared Jun 02, 1986
MONSANTO SANTOPRENE (PERITONE DEVICE)
K861683 · HIR
Peritone Research, Ltd.
Gastroenterology & Urology · 32d
Cleared Jun 02, 1986
RUBY & SAPPHIRE BLADE HOLDER
K861748 · HNN
Keeler Instruments, Inc.
Ophthalmic · 27d
Cleared Jun 02, 1986
BRUSHING
K861803
Beaute Naturelle International, Inc.
General & Plastic Surgery · 24d
Cleared Jun 02, 1986
LASER BRONCHOSCOPE SYSTEM
K861921 · LLO
Pilling Co.
Anesthesiology · 14d
Cleared Jun 02, 1986
LIDO BACK
K861986 · IKK
Loredan Biomedical, Inc.
Physical Medicine · 11d
Cleared May 30, 1986
BIOCHEM 515 RESPIRATION MONITOR
K854333 · BZQ
Biochem International, Inc.
Anesthesiology · 214d
Cleared May 30, 1986
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
K860076 · DTW
Gambro, Inc.
Cardiovascular · 142d
Cleared May 30, 1986
FAST FLOW XX (AQUEOUS SOLUTION FILTER)
K860372 · FPB
Healthtek, Inc.
General Hospital · 116d
Cleared May 30, 1986
URENAMEL, POSTERIOR RESTORATIVE MATERIAL
K860487 · EBF
Cadco Dental Products, Inc.
Dental · 109d
Cleared May 30, 1986
ES 180-DCM MUSCLE STIMULATOR
K860619 · IPF
Promatek
Physical Medicine · 100d
Cleared May 30, 1986
ENHANCE
K861041 · LYC
Packaging Technologies, Inc.
Dental · 73d
Cleared May 30, 1986
CURAMED 402 DIATHERMY UNIT
K861247 · IMJ
Henley Intl.
Physical Medicine · 58d
Cleared May 30, 1986
CURAPULS 419 DIATHERMY UNIT
K861248 · IMJ
Henley Intl.
Physical Medicine · 58d
Cleared May 30, 1986
OHMEDA POSI-PULSE SUCTION UNIT
K861261 · GCX
Ohmeda Medical
General Hospital · 56d
Cleared May 30, 1986
STOCKERT-SHILEY AORTIC ROOT CANNULAE
K861310 · DWF
Shiley, Inc.
Cardiovascular · 52d
Cleared May 30, 1986
RMI POROUS VENT PLUG
K861322 · DWF
Research Medical, Inc.
Cardiovascular · 52d
Cleared May 30, 1986
NEUTRALON SURGICAL GLOVES
K861441 · KGO
Surgikos, Inc.
General Hospital · 43d
Cleared May 30, 1986
MODEL DT-102 DATA TELEPHONE TRANSMITTER
K861455 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 42d
Cleared May 30, 1986
SURGICAL PACKS, KITS AND TRAYS
K861530 · FSM
Medical Concepts Development, Inc.
General & Plastic Surgery · 36d
Cleared May 30, 1986
TYPE 6500 HEARING AID ANALYZER
K861571 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 32d
Cleared May 30, 1986
ACS WHOLEY HI-TORQUE GUIDE WIRE
K861765 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 23d
Cleared May 30, 1986
CABOT VIDEOSCOPE
K861859 · HRX
Cabot Medical Corp.
Orthopedic · 16d
Cleared May 30, 1986
CRANIO BLADES AND WIRE PASS DRILL
K861876 · GFA
New England Surgical Instrument Corp.
General & Plastic Surgery · 15d