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
102697–102720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1995
CMT-1000
K942428 · LIH
Ems, Inc.
Neurology · 368d
Cleared May 23, 1995
TC 3000
K942881 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 340d
Cleared May 23, 1995
PROSTAT CONTROL
K943394 · JJY
Quantimetrix Corp.
Immunology · 313d
Cleared May 23, 1995
ORTHODONTIC ELASTOMERIC TUBE/THREAD
K943417 · ECI
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
ORTHODONTIC ELASTOMERIC SEPARATOR MODULE
K943418 · ECI
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
ORTHODONTIC ELASTOMERIC CHAIN
K943420 · ECI
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
ORTHODONITC ELASTOMERIC SLEEVING
K943421 · DZD
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
TRIADYNE
K944094 · FNM
Kinetic Concepts, Inc.
General Hospital · 274d
Cleared May 23, 1995
LIFECARE 175 INFUSER, MODIFICATION
K944190 · FRN
Abbott Laboratories
General Hospital · 309d
Cleared May 23, 1995
OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
K945267 · HRX
Optus, Inc.
Orthopedic · 207d
Cleared May 23, 1995
ALTRA FLUX(TM) 170 HEMODIALYZER
K945542 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 190d
Cleared May 23, 1995
CATCO THORACIC CATHETER
K945728 · JOL
Catco Medical, Inc.
General Hospital · 182d
Cleared May 23, 1995
CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM
K946165 · HRS
Elekta Instruments, Inc.
Orthopedic · 155d
Cleared May 23, 1995
SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR
K950284 · FOZ
Sims Deltec, Inc.
General Hospital · 119d
Cleared May 23, 1995
CEREC 2
K950299 · ELW
Pelton & Crane Co.
Dental · 118d
Cleared May 23, 1995
CONAIR BODY AND SOLE
K950410 · IRO
Conair Corp.
Physical Medicine · 112d
Cleared May 23, 1995
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND...
K950629 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 99d
Cleared May 23, 1995
SAFE-TIPS EZ
K951238 · EIA
Safe Wave Products, Inc.
Dental · 64d
Cleared May 23, 1995
E-PACK PROCEDURE KITS
K951476 · MCY
Ethicon, Inc.
General & Plastic Surgery · 54d
Cleared May 23, 1995
MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER
K951515 · FMI
Sherwood Medical Co.
General Hospital · 50d
Cleared May 23, 1995
FUJI IX
K951555 · EMA
GC America, Inc.
Dental · 49d
Cleared May 23, 1995
BAND SEATER
K951776 · ECR
Ormco Corp.
Dental · 40d
Cleared May 23, 1995
PRIME & BOND DIRECT COMPOSITE BONDING AGENT
K951864 · KLE
Dentsply Intl.
Dental · 32d
Cleared May 23, 1995
PERMAQUIK BONDING PRIMER
K951867 · KLE
Ultradent Products, Inc.
Dental · 32d