FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87937–87960 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1998
SWEEN WOUN'DRES
K983042 · MGQ
Coloplast Corp.
General & Plastic Surgery · 86d
Cleared Nov 25, 1998
AMIELLE
K983045 · KXP
Owen Mumford USA, Inc.
Obstetrics & Gynecology · 85d
Cleared Nov 25, 1998
PNEUMATIC CUTTER SYSTEM
K983050 · ERL
Surgical Laser Technologies, Inc.
Ear, Nose, Throat · 85d
Cleared Nov 25, 1998
MEDISYSTEMS TRANSDUCER PROTECTOR
K983076 · FIB
Medisystems Corp.
Gastroenterology & Urology · 84d
Cleared Nov 25, 1998
DEPUY LUSTER STEM
K983136 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 78d
Cleared Nov 25, 1998
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K983150 · LPN
Allergan, Inc.
Ophthalmic · 77d
Cleared Nov 25, 1998
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
K983234 · MGP
Johnson & Johnson Medical, Div. of...
General & Plastic Surgery · 71d
Cleared Nov 25, 1998
SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN
K983249 · FRO
Euromed, Inc.
General & Plastic Surgery · 70d
Cleared Nov 25, 1998
SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
K983259 · JWY
Ab Biodisk
Microbiology · 70d
Cleared Nov 25, 1998
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT...
K983278 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 69d
Cleared Nov 25, 1998
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K983291 · MRC
Ciba Vision Corporation
Ophthalmic · 65d
Cleared Nov 25, 1998
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
K983301 · JWY
Accumed Intl., Inc.
Microbiology · 65d
Cleared Nov 25, 1998
DCI ENDOSCOPE
K983384 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 61d
Cleared Nov 25, 1998
BIOSTREP A-DIRECT STREP A ANTIGEN TEST
K983386 · GTY
Princeton BioMeditech Corp.
Microbiology · 60d
Cleared Nov 25, 1998
HOFFMANN II MIAMI POST
K983419 · HRS
Howmedica Corp.
Orthopedic · 57d
Cleared Nov 25, 1998
ABBOTT ARCHITECT TOTAL T4
K983440 · KLI
Abbott Laboratories
Chemistry · 57d
Cleared Nov 25, 1998
PRECISET SERUM PROTEINS CALIBRATOR
K983469 · JIX
Boehringer Mannheim Corp.
Chemistry · 55d
Cleared Nov 25, 1998
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K983726 · LCP
Genzyme Corp.
Chemistry · 34d
Cleared Nov 25, 1998
AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O...
K983788 · GEI
Aaron Medical Industries
General & Plastic Surgery · 29d
Cleared Nov 25, 1998
SPECTRUM SMALL FRY
K983859 · IOR
Freedom Designs, Inc.
Physical Medicine · 30d
Cleared Nov 25, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
K983895 · JZG
Beckman Coulter, Inc.
Immunology · 22d
Cleared Nov 25, 1998
ARTHRO-SURGIMAT-1500
K983910 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 22d
Cleared Nov 25, 1998
MODIFICATION TO BIO-LOGIC SLEEPSCAN
K983913 · OLV
Bio-Logic Systems Corp.
Neurology · 21d
Cleared Nov 25, 1998
DORNIER MEDILA H
K983963 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 19d