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
87241–87264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1998
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983350 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 79d
Cleared Dec 11, 1998
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983351 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 79d
Cleared Dec 11, 1998
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
K983352 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 79d
Cleared Dec 11, 1998
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
K983382 · MEH
Osteonics Corp.
Orthopedic · 77d
Cleared Dec 11, 1998
SURECAUT DIAMOND LASER KNIFE
K983463 · GEX
Clinicon Corp.
General & Plastic Surgery · 71d
Cleared Dec 11, 1998
VERTICAL LIFT
K983526 · ING
Barnes,Richardson & Colburn
Physical Medicine · 64d
Cleared Dec 11, 1998
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K983599 · HHT
Andwin Scientific
Microbiology · 58d
Cleared Dec 11, 1998
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
K983628 · GCT
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 57d
Cleared Dec 11, 1998
SEARE BIOMEDICAL SILICONE RODS
K983630 · MIB
Seare Biomedical Corp.
General & Plastic Surgery · 57d
Cleared Dec 11, 1998
MAX-ACT
K983649 · JBP
Array Medical, Inc.
Hematology · 56d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
K983697 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
K983699 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
K983700 · JXN
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
K983703 · DJR
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K983718 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Dec 11, 1998
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
K983729 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 50d
Cleared Dec 11, 1998
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE
K983730 · LZA
Omnigrace , Ltd.
General Hospital · 50d
Cleared Dec 11, 1998
INJECTION NEEDLE PROBE/DEVICE-TUNIS
K983765 · FBK
Ximed/Prosure/Injectx
Gastroenterology & Urology · 46d
Cleared Dec 11, 1998
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
K983792 · LCJ
Seare Biomedical Corp.
General & Plastic Surgery · 45d
Cleared Dec 11, 1998
PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE
K983821 · LLZ
Philips Medical Systems North...
Radiology · 43d
Cleared Dec 11, 1998
FV-RF
K984111 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 24d
Cleared Dec 11, 1998
MODIFICATION TO PROWESS PRO-SIM
K984196 · MUJ
Ssgi Prowess Systems
Radiology · 18d
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
K984272 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 11d