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
95161–95184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1996
VITLITE (TR7700)
K963417 · MPA
Escalon Trek Medical
Ophthalmic · 112d
Cleared Dec 20, 1996
AUTO SUTURE* ABBI* SYSTEM
K963825 · KNW
United States Surgical, A Division of...
Gastroenterology & Urology · 87d
Cleared Dec 20, 1996
HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR...
K963837 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 87d
Cleared Dec 20, 1996
KSEA UNIMAT PLUS
K963960 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 79d
Cleared Dec 20, 1996
ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
K964215 · HRX
Smith & Nephew Endoscopy, Inc.
Orthopedic · 59d
Cleared Dec 20, 1996
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
K964222 · LYL
Paladin Medical, Inc.
Ophthalmic · 59d
Cleared Dec 20, 1996
SURGIFORM ANATOMICAL MALAR
K964443 · LZK
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 44d
Cleared Dec 20, 1996
CURITY THORACENTESIS TRAY
K964519 · GCX
Kendall Healthcare Products Co....
General Hospital · 38d
Cleared Dec 20, 1996
A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON
K964621 · GEI
Alto Development Corp.
General & Plastic Surgery · 32d
Cleared Dec 20, 1996
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
K964774 · LZU
Fci Ophthalmics, Inc.
Ophthalmic · 59d
Cleared Dec 20, 1996
EL DORADO 55
K964788 · EJT
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 20, 1996
LA PLATA 39
K964789 · EJT
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 20, 1996
LA PLATA 40
K964792 · EJT
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 20, 1996
PACIFIC 56 (CB-40)
K964837 · EJT
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 20, 1996
PALLADIA 85 (PM-13)
K964838 · EJT
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 19, 1996
IRT LOCKING SYRINGE
K945410 · FMF
Interventional Research Technologies
General Hospital · 777d
Cleared Dec 19, 1996
SAFESKIN
K962139 · LZA
Safeskin Corp.
General Hospital · 199d
Cleared Dec 19, 1996
NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
K962518 · LZA
P.T. Irama Dinamika Latex
General Hospital · 175d
Cleared Dec 19, 1996
PELVIC HOLDER
K963465 · FMQ
Deroyal Industries, Inc.
General Hospital · 107d
Cleared Dec 19, 1996
CHLOROPRENE EXAM GLOVES
K963771 · LZA
P.T. Irama Dinamika Latex
General Hospital · 91d
Cleared Dec 19, 1996
KSEA UNIMAT PLUS
K963949 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 78d
Cleared Dec 19, 1996
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
K963959 · MEH
Osteonics Corp.
Orthopedic · 78d
Cleared Dec 19, 1996
MICADENT
K964059 · KOJ
Hampton Research
Dental · 71d
Cleared Dec 19, 1996
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT
K964828 · LRJ
S.C. Johnson & Son, Inc.
General Hospital · 17d