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
113305–113328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1993
URINARY CARE SUPPLIES
K923496 · KNY
Orion Life Systems, Inc.
Gastroenterology & Urology · 316d
Cleared May 27, 1993
MON-A-THERM FOLEY KIT
K923538 · FCM
Mallinckrodt Medical
Gastroenterology & Urology · 315d
Cleared May 27, 1993
Q3 DISPOSABLE PROPHY ANGLE
K923980 · EGS
Q3 Special Products, Inc.
Dental · 293d
Cleared May 27, 1993
ISS O-RING ATTACHMENT
K924190 · DZE
Implant Support Systems, Inc.
Dental · 280d
Cleared May 27, 1993
CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272
K924234 · KOI
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 276d
Cleared May 27, 1993
DERMAGRAN WOUND DRESSING
K924754 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 246d
Cleared May 27, 1993
FORESTADENT BRACKETS
K924971 · EJF
Forestadent Bernhard Forster GmbH
Dental · 239d
Cleared May 27, 1993
ATRIUM'S HYBRID PTFE
K925123 · DSY
Atrium Medical Corp.
Cardiovascular · 226d
Cleared May 27, 1993
MICODOSE CHLORHEXIPREP
K925163 · ECM
Unicep
Dental · 226d
Cleared May 27, 1993
CORRECT AND CORRECT FIT II
K925331 · EJS
Jeneric/Pentron, Inc.
Dental · 218d
Cleared May 27, 1993
DUAL LUMEN L-CATH CATHETER SYSTEM
K925979 · DQX
Luther Medical Products, Inc.
Cardiovascular · 183d
Cleared May 27, 1993
BIO C & B
K926146 · EJS
Jeneric/Pentron, Inc.
Dental · 171d
Cleared May 27, 1993
GOLD-PLATINUM BASED CASTING ALLOY
K926147 · EJS
Jeneric/Pentron, Inc.
Dental · 171d
Cleared May 27, 1993
NEW LEAD INTRODUCER KITS, VARIOUS MODELS
K926340 · DYB
Telectronics Pacing Systems, Inc.
Cardiovascular · 161d
Cleared May 27, 1993
DUCERANIUM U
K926347 · EJH
Degussa AG
Dental · 161d
Cleared May 27, 1993
TITAN SEPARATING SPRING
K930202 · DZC
Ortho Spectrum, Inc.
Dental · 133d
Cleared May 27, 1993
SINGLES
K930453 · ECI
Nexadental
Dental · 120d
Cleared May 27, 1993
NEW DENTIN PRIMER
K930504 · KLE
Dentsply Intl.
Dental · 115d
Cleared May 27, 1993
ENDO-ICE-PULP TESTER-THERMAL
K930764 · EAT
The Hygenic Corp.
Dental · 104d
Cleared May 27, 1993
TEMPIT
K931084 · EMA
Centrix, Inc.
Dental · 86d
Cleared May 27, 1993
CLEANCUFF(TM)
K931087 · DXQ
Med-Con, Inc.
Cardiovascular · 85d
Cleared May 27, 1993
DURAFLOR
K931096 · LBH
Pharmascience, Inc.
Dental · 85d
Cleared May 27, 1993
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · DYB
Cordis Corp.
Cardiovascular · 85d
Cleared May 27, 1993
KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH
K931162 · ELM
King Dental Corp.
Dental · 80d