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
138121–138144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1987
TUMORIMETER
K874352 · FTY
Cancer Technologies, Inc.
General & Plastic Surgery · 31d
Cleared Nov 23, 1987
PIN PUNCH
K874356 · LRY
Med-Tool, Inc.
General & Plastic Surgery · 31d
Cleared Nov 23, 1987
TAPERED PUNCH
K874357 · LRY
Med-Tool, Inc.
General & Plastic Surgery · 31d
Cleared Nov 23, 1987
COMBINATION WRENCHES
K874358 · HXC
Med-Tool, Inc.
Orthopedic · 31d
Cleared Nov 23, 1987
ADJUSTABLE WRENCHES
K874359 · HXC
Med-Tool, Inc.
Orthopedic · 31d
Cleared Nov 23, 1987
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
K874376 · JXM
Syva Co.
Toxicology · 28d
Cleared Nov 23, 1987
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
K874394 · DXY
Intermedics, Inc.
Cardiovascular · 26d
Cleared Nov 23, 1987
BICARBONATE
K874435 · KHS
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Nov 23, 1987
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010
K874477 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BARBITURATES
K874483 · DIS
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX PHENCYCLIDINE
K874484 · LCL
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR OPIATES
K874485 · DJG
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
K874486 · DKZ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX COCAINE METABOLITE
K874487 · DIO
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX CANNABINOIDS
K874488 · LDJ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
K874489 · JXM
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
KAMBIN LAMINECTOMY FRAME
K874494 · LWG
Avec Scientific Design Corp.
General & Plastic Surgery · 21d
Cleared Nov 23, 1987
MICROTEK MINI-MAX DRILL SYSTEM
K874535 · DZI
Microtek Medical, Inc.
Dental · 20d
Cleared Nov 20, 1987
LUBRICATED CONDOM
K872504 · HIS
Royal American Industries, Inc.
Obstetrics & Gynecology · 149d
Cleared Nov 20, 1987
BINAX EQUATE STREP B
K872904 · GTZ
Binax, Inc.
Microbiology · 119d
Cleared Nov 20, 1987
CLEARFIL PHOTO BOND
K872959 · KLE
Kuraray Co.
Dental · 114d
Cleared Nov 20, 1987
TORAY ANTHRON ANGIOGRAPHIC CATHETERS
K872983 · DQR
Toray Industries (America), Inc.
Cardiovascular · 112d
Cleared Nov 20, 1987
PLATELET EXTRACT REAGENT
K873382 · GGW
Bio/Data Corp.
Hematology · 88d
Cleared Nov 20, 1987
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · JJQ
Helena Laboratories
Hematology · 88d