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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
139705–139728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1987
MODEL 5000 AMBULATORY MONITORING SYSTEM
K871500 · GWQ
Oxford Medilog, Inc.
Neurology · 76d
Cleared Jul 01, 1987
PFI-20 POLARIZING FLUORIMETER
K871550 · KHO
The Perkin-Elmer Corp.
Chemistry · 70d
Cleared Jul 01, 1987
PHENYTOIN FPIA CONTROLS
K871567 · LAS
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared Jul 01, 1987
KEYFILL
K872053 · CAD
Mayfield Instruments, Ltd.
Anesthesiology · 30d
Cleared Jul 01, 1987
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
K872110 · JIF
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Jul 01, 1987
MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT
K872252 · LGD
Labsystems, Inc.
Microbiology · 20d
Cleared Jul 01, 1987
IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
K872305 · JLW
Diagnostic Products Corp.
Chemistry · 23d
Cleared Jul 01, 1987
JOVI MYELOGRAPHY HARNESS
K872468 · KPR
Jovi, Inc.
Radiology · 8d
Cleared Jun 30, 1987
SURGISTEEL
K865038 · GAQ
Sutures , Ltd.
General & Plastic Surgery · 188d
Cleared Jun 30, 1987
ANTERIOR SPINAL FIXATION PLATE
K870085 · KWP
Terray Manufacturing, Inc.
Orthopedic · 173d
Cleared Jun 30, 1987
ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS
K871715 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 57d
Cleared Jun 30, 1987
SARMIENTO FOREARM NAIL
K871814 · HSB
Depuy, Inc.
Orthopedic · 50d
Cleared Jun 30, 1987
BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS.
K872099 · NAD
The Bfgoodrich Co.
General & Plastic Surgery · 29d
Cleared Jun 30, 1987
BIOFILM TRANSORBENT ULCER AND WOUND DRESSING
K872100 · NAD
The Bfgoodrich Co.
General & Plastic Surgery · 29d
Cleared Jun 30, 1987
BIOFILM TRANS. POUCH ULCER & WOUND DRESSING
K872101 · NAD
The Bfgoodrich Co.
General & Plastic Surgery · 29d
Cleared Jun 30, 1987
XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.
K872168 · LXB
Xomed, Inc.
Ear, Nose, Throat · 22d
Cleared Jun 30, 1987
SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER
K872225 · KOT
Block Drug Company, Inc.
Dental · 21d
Cleared Jun 29, 1987
ROBINJECT
K864984 · KZE
International Medical Products, Inc.
General Hospital · 189d
Cleared Jun 29, 1987
MODIFIED SALTEX REAGENT STRIPS
K870214 · CHK
Miles Laboratories, Inc.
Chemistry · 160d
Cleared Jun 29, 1987
NIGHTWATCH(TM) SYSTEM
K870578 · DSH
Buckman Co., Inc.
Cardiovascular · 139d
Cleared Jun 29, 1987
DORCHES(TM) LIFESOUND(TM)
K870810 · DQD
Centauri Manufacturing, Inc.
Cardiovascular · 118d
Cleared Jun 29, 1987
ULTIMATE PROTECTIVE SAFETY CAP (UPS CAP)
K871142 · FMI
Peachtree Medical, Inc.
General Hospital · 98d
Cleared Jun 29, 1987
LES RAD FILTER
K871227 · ITY
M. D. Products
Radiology · 94d
Cleared Jun 29, 1987
KINESTIM MUSCLE STIMULATOR
K871472 · IPF
Promatek Industries, Ltd.
Physical Medicine · 76d