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
108241–108264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1994
MODEL 2100 MILD INTERMITTENT SUCTION PUMP
K941524 · JCX
Product & Educational Services
General & Plastic Surgery · 48d
Cleared May 17, 1994
SUNGLASSES
K941590 · HQY
Avon Products, Inc.
Ophthalmic · 47d
Cleared May 17, 1994
SUNGLASSES
K941629 · HQY
Kuang Yauh Optical Co., Ltd.
Ophthalmic · 43d
Cleared May 17, 1994
SUNGLASSES
K941638 · HQY
Sun Coast Merchandise Corp.
Ophthalmic · 43d
Cleared May 17, 1994
BLUE PLANET LENS FOG REDUCTION & CLEANING KIT
K941648 · FEB
Blue Planet Industries, Inc.
General Hospital · 43d
Cleared May 17, 1994
SUNGLASSES
K941668 · HQY
Yon'S Jay Enterprise Co., Ltd.
Ophthalmic · 42d
Cleared May 17, 1994
COOL KIDS BEADS AND SHADES
K941682 · HQY
Ja-Ru, Inc.
Ophthalmic · 42d
Cleared May 17, 1994
SUNGLASSES
K941732 · HQY
Pacific Eyes & T'S
Ophthalmic · 40d
Cleared May 17, 1994
SUNGLASSES
K941786 · HQY
Modo Eyewear USA
Ophthalmic · 36d
Cleared May 17, 1994
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · DPS
Hewlett-Packard Co.
Cardiovascular · 35d
Cleared May 17, 1994
SUN FILTERS/SHIELDS
K941829 · HOY
Klinger Eye Shields, Inc.
Ophthalmic · 34d
Cleared May 17, 1994
SUNGLASSES
K941930 · HQY
Sunvista Import, Inc.
Ophthalmic · 27d
Cleared May 17, 1994
RETRACTOR
K942002 · GAD
Automated Medical Products Corp.
General & Plastic Surgery · 22d
Cleared May 17, 1994
E2550 REUSABLE HANDSWITCHING PENCIL
K942183 · GEI
Valleylab, Inc.
General & Plastic Surgery · 13d
Cleared May 16, 1994
PERIOFLEX TIP
K923711 · EFS
Novadent, Ltd.
Dental · 658d
Cleared May 16, 1994
CABOT MEDICAL UTERINE RESECTOSCOPE
K924631 · HIH
Cabot Medical Corp.
Obstetrics & Gynecology · 609d
Cleared May 16, 1994
REUSABLE LAPAROSCOPIC INSTRUMENTS
K930667 · GCJ
Snowden-Pencer
General & Plastic Surgery · 461d
Cleared May 16, 1994
VESPHENE II
K931573 · LRJ
Calgon Vestal Div.
General Hospital · 412d
Cleared May 16, 1994
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
K933102 · LPH
Howmedica Corp.
Orthopedic · 326d
Cleared May 16, 1994
ONGARD 3 QUART SHARPS CONTAINER
K933274 · FMI
Ongard Systems, Inc.
General Hospital · 314d
Cleared May 16, 1994
EUROFORM TOTAL HIP PROSTHESIS
K933567 · LZO
Landos, Inc.
Orthopedic · 298d
Cleared May 16, 1994
ONGARD 2 GALLON CHEMO SHARPS CONTAINER
K933674 · FMI
Ongard Systems, Inc.
General Hospital · 292d
Cleared May 16, 1994
MICROVASIVE MAXFORCE
K934697 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 228d
Cleared May 16, 1994
KAVO INTRASEPT 905
K934783 · EIA
Kavo America
Dental · 222d