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
116641–116664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1992
MRT-50A QD SPINE COIL
K921720 · LNH
Toshiba America Mri, Inc.
Radiology · 98d
Cleared Jul 16, 1992
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
K921758 · HQE
Storz Instrument Co.
Ophthalmic · 94d
Cleared Jul 16, 1992
CYNOSURE PHOTOTRIPTER LASER
K921840 · GEX
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Jul 16, 1992
CBIS CATHETER PULL-BACK DEVICE
K921879 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Jul 16, 1992
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
K921939 · LAS
Heraeus Kulzer, Inc.
Toxicology · 83d
Cleared Jul 16, 1992
OLYMPUS GLUCOSE REAGENT
K922232 · CFR
Olympus Corp.
Chemistry · 65d
Cleared Jul 16, 1992
TESTPACK PLUS STREP A
K922345 · GTZ
Abbott Laboratories
Microbiology · 58d
Cleared Jul 16, 1992
OLYMPUS TOTAL PROTEIN REAGENT
K922361 · CEK
Olympus Corp.
Chemistry · 58d
Cleared Jul 15, 1992
NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
K920379 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 168d
Cleared Jul 15, 1992
HOOK SURGICAL INSTRUMENT
K920599 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 155d
Cleared Jul 15, 1992
PRE-STERILIZED ITI DENTAL IMPLANTS
K920928 · DZE
The Straumann Co.
Dental · 138d
Cleared Jul 15, 1992
MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM
K921801 · JEY
Techmedica, Inc.
Dental · 93d
Cleared Jul 15, 1992
TOMEY PE-300 PORTABLE ERG
K921815 · HLT
Tomey Corporation USA
Ophthalmic · 91d
Cleared Jul 15, 1992
INTRADUCER
K921934 · GBX
Taut, Inc.
General & Plastic Surgery · 82d
Cleared Jul 15, 1992
KING DIAGNOSTICS AST (GOT) REAGENT
K922108 · CIT
King Diagnostics, Inc.
Chemistry · 71d
Cleared Jul 15, 1992
DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL
K922387 · DDR
Baxter Diagnostics, Inc.
Immunology · 56d
Cleared Jul 15, 1992
TETRIC LIGHT-CURING COMPOSITE
K922569 · EBF
Ivoclar North America, Inc.
Dental · 44d
Cleared Jul 15, 1992
SLT LASER DELIVERY SYSTEM
K922634 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 50d
Cleared Jul 14, 1992
MONOTUBE EXTERNAL FIXATION SYSTEM
K910483 · KTT
Howmedica Corp.
Orthopedic · 524d
Cleared Jul 14, 1992
DERMAGRAN WET DRESSING (ZINC-SALINE)
K913344 · MGQ
Derma Sciences, Inc.
General & Plastic Surgery · 354d
Cleared Jul 14, 1992
ACCUTRACKER DX
K913844 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 321d
Cleared Jul 14, 1992
UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER
K914538 · DQA
Innovative Medical Products, Inc.
Anesthesiology · 277d
Cleared Jul 14, 1992
BLOOD GAS/ISE LINEARITY CONTROL
K920285 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 174d
Cleared Jul 14, 1992
WAKO AUTOKIT MICRO TP
K920531 · CEK
Wako Chemicals USA, Inc.
Chemistry · 160d