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
100729–100752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1995
AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING
K954223 · ELW
American Dental Products, Inc.
Dental · 18d
Cleared Sep 29, 1995
TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE
K954265 · KNW
Promex, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 28, 1995
PATTON LAPAROSCOPIC CATHETER INTRODUCER SET
K940265 · HET
Cook Urological, Inc.
Obstetrics & Gynecology · 615d
Cleared Sep 28, 1995
AM-50 AEROSOL/MEDICATION AIR COMPRESSOR
K945478 · BTI
Preferred Medical Supply, Inc.
Anesthesiology · 324d
Cleared Sep 28, 1995
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY
K951737 · FOS
Sherwood Medical Co.
General Hospital · 167d
Cleared Sep 28, 1995
STRYKER ACL INTERFERENCE SCREW SYSTEM
K952460 · HWC
Stryker Endoscopy
Orthopedic · 125d
Cleared Sep 28, 1995
B & L ELECTRODE
K952655 · IKN
B & L Engineering
Neurology · 143d
Cleared Sep 28, 1995
BILI-METER
K953005 · JJQ
Olympic Medical Corp.
Chemistry · 92d
Cleared Sep 28, 1995
TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET
K953028 · MEB
I-Flow Corp.
General Hospital · 91d
Cleared Sep 28, 1995
DIGITAL IMAGING SYSTEM INTERFACE
K953080 · LMD
Camtronics, Ltd.
Radiology · 87d
Cleared Sep 28, 1995
LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM
K953385 · JEY
Walter Lorenz Surgical, Inc.
Dental · 71d
Cleared Sep 28, 1995
SHAPING HEDSTROM N.T.
K953604 · EKS
Sybron Dental Specialties, Inc.
Dental · 57d
Cleared Sep 28, 1995
ALTADYNE
K953675 · FNM
Lumex, Inc.
General Hospital · 52d
Cleared Sep 28, 1995
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
K953952 · DXQ
Deroyal Industries, Inc.
Cardiovascular · 37d
Cleared Sep 28, 1995
MAICO PRODIGY CIC SERIES
K954054 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 28, 1995
3M MODEL 8295
K954067 · ESD
3M Company
Ear, Nose, Throat · 29d
Cleared Sep 27, 1995
ANGLED 3.25 MM DENTAL IMPLANT ATTACHMENTS
K926371 · DZE
International Implant Seminars
Dental · 1009d
Cleared Sep 27, 1995
HUBER NEEDLE SETS
K933898 · FPA
Mediziv Medical Products 1987 , Ltd.
General Hospital · 778d
Cleared Sep 27, 1995
OXY-GENERATOR
K941145 · CAW
Med Systems
Anesthesiology · 566d
Cleared Sep 27, 1995
ENDOLUMINAL ACCESS TUBE
K941228 · KNT
Med Institute, Inc.
Gastroenterology & Urology · 561d
Cleared Sep 27, 1995
E. COLI 0157 ELISA STOOL ASSAY
K942705 · GMZ
Lmd Laboratories
Microbiology · 476d
Cleared Sep 27, 1995
DUAL INTEGRATOR DENTAL IMPLANT
K944225 · DZE
Implant Integration Systems, Inc.
Dental · 393d
Cleared Sep 27, 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
K950204 · DZE
Implant Innovations, Inc.
Dental · 252d
Cleared Sep 27, 1995
URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
K951260 · KOD
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 190d