FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83713–83736 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2000
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · JMO
Dade Behring, Inc.
Chemistry · 53d
Cleared Jan 28, 2000
IMPREGUM PENTA M MONOSOFT
K994192 · ELW
Espe Dental AG
Dental · 46d
Cleared Jan 28, 2000
IMPREGUM PENTA DUOSOFT
K994193 · ELW
Espe Dental AG
Dental · 46d
Cleared Jan 28, 2000
SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES...
K994248 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 43d
Cleared Jan 27, 2000
GAMBRO DQM 200
K990039 · LFP
Gambro Healthcare
Chemistry · 386d
Cleared Jan 27, 2000
STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM...
K991023 · FRG
Case Medical, Inc.
General Hospital · 304d
Cleared Jan 27, 2000
METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
K991355 · CAF
Instrumentation Industries, Inc.
Anesthesiology · 283d
Cleared Jan 27, 2000
EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
K991935 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 232d
Cleared Jan 27, 2000
ELECTROSURGICAL ELECTRODE FAMILY
K992045 · GEI
Genesis Medical, Inc.
General & Plastic Surgery · 224d
Cleared Jan 27, 2000
EMS KERMIT
K992504 · ELC
(Ems Sa) Electro Medical Systems
Dental · 184d
Cleared Jan 27, 2000
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
K992632 · DKZ
Diagnostic Products Corp.
Toxicology · 174d
Cleared Jan 27, 2000
EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000
K992914 · GEX
Acculase, Inc.
General & Plastic Surgery · 150d
Cleared Jan 27, 2000
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
K992991 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 142d
Cleared Jan 27, 2000
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
K993026 · DIP
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS
K993028 · KLT
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · KLS
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS
K993031 · DLZ
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL...
K993639 · LIT
Guidant Corp.
Cardiovascular · 91d
Cleared Jan 27, 2000
NEUROCOMP
K993654 · HCC
Neurocybernetics
Neurology · 90d
Cleared Jan 27, 2000
UNIGRAFT
K993784 · LYC
Unicare Biomedical
Dental · 80d
Cleared Jan 27, 2000
MILLENNIUM HUBER PLUS SAFETY INFUSION SET
K993848 · FPA
Millennium Medical Distribution, Inc.
General Hospital · 76d
Cleared Jan 27, 2000
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · LAF
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
K993983 · LCM
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985 · JXM
Syva Co.
Toxicology · 64d