Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
156913–156936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1983
BRONCHO-FIBERSCOPE
K832010 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 39d
Cleared Aug 01, 1983
EMIT AED PHENYTOIN ASSAY
K832033 · DIP
Syva Co.
Chemistry · 39d
Cleared Aug 01, 1983
EMIT AAD THEOPHYLLINE ASSAY
K832034 · KLS
Syva Co.
Chemistry · 39d
Cleared Aug 01, 1983
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K832074 · HKP
CooperVision, Inc.
Ophthalmic · 34d
Cleared Aug 01, 1983
PHONIC EAR PE 467R-PE 461T
K832080 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 34d
Cleared Aug 01, 1983
PHONIC EAR PE 845PPC-D
K832081 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 34d
Cleared Aug 01, 1983
DICON GLAUCOMA DIAG. CENTER 2000 SERIES
K832142 · HPT
CooperVision, Inc.
Ophthalmic · 27d
Cleared Aug 01, 1983
SPLINT WOOD
K832144 · ILH
Vermont Wood Industries, Inc.
Physical Medicine · 32d
Cleared Aug 01, 1983
AMBULIZER MODEL MC-5
K832161 · IOR
Mobilizer Medical Products, Inc.
Physical Medicine · 27d
Cleared Jul 29, 1983
VITALINE 2
K822856
American Heartline, Inc.
Cardiovascular · 305d
Cleared Jul 29, 1983
DISPOSABLE MICROTOME BLADES
K831921 · IDL
Polymer Technology Corp.
Pathology · 45d
Cleared Jul 29, 1983
EMBEDDING RING
K831922 · KER
Polymer Technology Corp.
Pathology · 45d
Cleared Jul 29, 1983
LKB 2164 MACRO-SPIN R CENTRIFUGE
K831942 · JQC
Lkb Instruments, Inc.
Chemistry · 43d
Cleared Jul 29, 1983
LKB 2160 MIDISPIN CENTRIFUGE
K831947 · JQC
Lkb Instruments, Inc.
Chemistry · 43d
Cleared Jul 29, 1983
LKB 2161 MIDISPIN R CENTRIFUGE
K831948 · JQC
Lkb Instruments, Inc.
Chemistry · 43d
Cleared Jul 28, 1983
AMBULATORY ECG EVENT RECORDER
K830907 · DSH
Brentwood Instruments, Inc.
Cardiovascular · 129d
Cleared Jul 28, 1983
UNICUFF-BLOOD PRESSURE CUFF
K831001 · DXQ
Frontier Products
Cardiovascular · 121d
Cleared Jul 28, 1983
INTRA-ORAL ARTIFICIAL LARYNX
K831127 · ESE
Xomed, Inc.
Ear, Nose, Throat · 113d
Cleared Jul 28, 1983
LIFESTAT 200
K831232 · DXN
Physio-Control Corp.
Cardiovascular · 104d
Cleared Jul 28, 1983
PRO QUANTUM
K831249 · JQW
Abbott Laboratories
Chemistry · 101d
Cleared Jul 28, 1983
TISSUE-TEK V.I.P. 100/200
K831313 · IEO
Miles Laboratories, Inc.
Pathology · 97d
Cleared Jul 28, 1983
MODEL 947 VIDEO BLOOD GAS SYS
K831379 · CHL
Avl Scientific Corp.
Chemistry · 91d
Cleared Jul 28, 1983
DNA FLOR
K831408 · DHN
Medastat Scientific Corp.
Immunology · 87d
Cleared Jul 28, 1983
SILCATH CENTRAL CATHETER TRAY W/18 GA
K831453 · JCY
Argon Medical Corp.
General & Plastic Surgery · 84d