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
109369–109392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1994
OXISAT
K934091 · DQA
Marquette Electronics, Inc.
Anesthesiology · 204d
Cleared Mar 15, 1994
FACTOR VIII DEFICIENT PLASMA
K935057 · GJT
Sigma Diagnostics, Inc.
Hematology · 145d
Cleared Mar 15, 1994
DIPRIVAN LUER CONNECTOR
K935274 · LHI
Ohmeda Medical
General Hospital · 132d
Cleared Mar 15, 1994
TORQUE DEVICE
K936032 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 88d
Cleared Mar 15, 1994
DENTIN CONDITIONING AND ADHESIVE SYSTEM
K936222 · KLE
Jeneric/Pentron, Inc.
Dental · 76d
Cleared Mar 15, 1994
GLYCATED HEMOGLOBIN CONTROLS
K940143 · LCP
Primus Corp.
Hematology · 63d
Cleared Mar 15, 1994
VERSADOWEL POST SYSTEM
K940680 · ELR
Dental Power, Inc.
Dental · 33d
Cleared Mar 14, 1994
HASKEL CPR
K922093 · DRM
Haskel, Inc.
Cardiovascular · 678d
Cleared Mar 14, 1994
PEGASUS
K925178 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 516d
Cleared Mar 14, 1994
HVGS 9000
K926084 · IPF
Shevlin Medical, Inc.
Physical Medicine · 467d
Cleared Mar 14, 1994
TERRA FEMME
K930400 · HEB
Bio Business Intl, Inc.
Obstetrics & Gynecology · 412d
Cleared Mar 14, 1994
MXT-2 12 LEAD MICRO-TRANSMITTER
K933012 · DXH
Medical Electronic Record Exchange
Cardiovascular · 266d
Cleared Mar 14, 1994
SYNTHES UNREAMED HUMERAL NAIL (URHN)
K933518 · HSB
Synthes (Usa)
Orthopedic · 237d
Cleared Mar 14, 1994
360 DEGREE FIXATION LIGHT
K933739 · HPL
Varitronics
Ophthalmic · 223d
Cleared Mar 14, 1994
HI-FLO INFUSION PUMP
K934671 · FRN
Abbott Laboratories
General Hospital · 166d
Cleared Mar 14, 1994
HOME MICROCURRENT HMC
K935132 · GZJ
Medical Devices, Inc.
Neurology · 137d
Cleared Mar 14, 1994
OPHTHALMIC SURGICAL SYSTEM
K935223 · HQC
Optical Micro Systems, Inc.
Ophthalmic · 133d
Cleared Mar 14, 1994
MAHE INSTRUMENTS
K935442 · GCJ
Mahe-Medizintechnik
General & Plastic Surgery · 122d
Cleared Mar 14, 1994
CEDIA DAU NEGATIVE CALIBRATOR
K935793 · DKB
Microgenics Corp.
Toxicology · 97d
Cleared Mar 14, 1994
MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE
K935814 · KNW
Boston Scientific Corp
Gastroenterology & Urology · 102d
Cleared Mar 14, 1994
SPORTS RADIO SUNGLASSES
K936027 · HQY
Vast Lea Enterprise Co. , Ltd.
Ophthalmic · 87d
Cleared Mar 14, 1994
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
K936028 · DKB
Microgenics Corp.
Toxicology · 87d
Cleared Mar 14, 1994
GAMMA LOCKING NAIL MODIFICATION
K940286 · KTT
Howmedica, Inc.
Orthopedic · 63d
Cleared Mar 14, 1994
NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS
K940463 · DQA
Nonin Medical, Inc.
Anesthesiology · 40d