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
113905–113928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1993
TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
K924191 · BTO
American Healthcare Corp.
Anesthesiology · 225d
Cleared Apr 01, 1993
HEWLETT-PACKARD MODEL 78730 CAREVUE 5000
K922210 · MHX
Hewlett-Packard Co.
Cardiovascular · 324d
Cleared Apr 01, 1993
M3 LAG SCREW FIXATION SYSTEM
K924018 · HWC
Osteomed Corp.
Orthopedic · 233d
Cleared Mar 31, 1993
IMPLANDRILL - THREADED DENTAL IMPLANT
K913404 · DZE
Impladrill , Ltd.
Dental · 610d
Cleared Mar 31, 1993
LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH.
K920334 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 429d
Cleared Mar 31, 1993
MDT/CASTLE 10/90 DUAL LOAD STATION
K920930 · FLF
Mdt Corp., Inc.
General Hospital · 397d
Cleared Mar 31, 1993
SONACARE SOUND MASSAGER
K921000 · ISA
Honor Trading, Ltd.
Physical Medicine · 398d
Cleared Mar 31, 1993
HILL-ROM VIA STRETCHER (P1300 - P1303)
K922808 · FPO
Hill-Rom, Inc.
General Hospital · 294d
Cleared Mar 31, 1993
GENERAL PROCEDURAL STRETCHERS (P880- P886)
K922809 · FPO
Hill-Rom, Inc.
General Hospital · 294d
Cleared Mar 31, 1993
DYNACYT BIOPSY ASPIRATION DEVICE
K922919 · MJG
Buckman Co., Inc.
General & Plastic Surgery · 287d
Cleared Mar 31, 1993
ORTHODONTIC BITE
K922984 · LRK
American Orthodontics
Dental · 282d
Cleared Mar 31, 1993
SWITCHABLE TIP SYSTEM
K923191 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 274d
Cleared Mar 31, 1993
APEX DIRECT BONDED BRACKETS
K923440 · EJF
Apex Orthodontics, Inc.
Dental · 261d
Cleared Mar 31, 1993
NATURAL-KNEE ALL-POLY TIBIA
K923443 · JWH
Intermedics Orthopedics
Orthopedic · 261d
Cleared Mar 31, 1993
MEDICOOL
K923643 · ILO
Micromedic Systems
Physical Medicine · 253d
Cleared Mar 31, 1993
TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS
K923815 · FYA
Laivan Corp.
General Hospital · 244d
Cleared Mar 31, 1993
DIMPLED MULTI MODULUS ARCH WIRE
K923837 · DZC
Ultimate Wireforms, Inc.
Dental · 244d
Cleared Mar 31, 1993
NK DIGI-GRIP SENSOR, MODEL DGR001
K923963 · LBB
Nk Biotechnical Engineering Co.
Neurology · 236d
Cleared Mar 31, 1993
ZOE LASER, CONTACT ND:YAG LASER SYSTEM
K923991 · GEX
Lca, Inc.
General & Plastic Surgery · 233d
Cleared Mar 31, 1993
OPTI-SHIELD
K924089 · EFB
Fuji Optical Systems, Inc.
Dental · 230d
Cleared Mar 31, 1993
EJECTOR
K924211 · DYN
Glenroe Technologies
Dental · 223d
Cleared Mar 31, 1993
RESTOBOND 4
K924378 · KLE
Lee Pharmaceuticals
Dental · 212d
Cleared Mar 31, 1993
LIDO(R) LINEA
K924513 · BXB
Loredan Biomedical, Inc.
Physical Medicine · 208d
Cleared Mar 31, 1993
ORTHODONTIC ARCH WIRE
K924805 · DZC
Ultimate Wireforms, Inc.
Dental · 188d