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
83209–83232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 27, 2000
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986 · KXS
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
K993987 · KLT
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
K993988 · DIO
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
K994004 · LSR
Inova Diagnostics, Inc.
Microbiology · 64d
Cleared Jan 27, 2000
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
K994017 · LCM
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
K994020 · LCM
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
ONTRAK TESTCUP 5, CAT. 07 6481 7
K994030 · LCM
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
AROMA FINE (NORMAL AND FAST SET)
K994077 · ELW
GC America, Inc.
Dental · 56d
Cleared Jan 27, 2000
IMPREGUM GARANT L DUOSOFT
K994190 · ELW
Espe Dental AG
Dental · 45d