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
138361–138384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1987
SPECTRAMED RESPIRATORY GAS ANALYZER
K873194 · CBS
Draeger Medical, Inc.
Anesthesiology · 78d
Cleared Oct 30, 1987
DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR
K873447 · BYH
Dhd Medical Products Div. Diemolding...
Anesthesiology · 74d
Cleared Oct 30, 1987
BLOOD ANALYSIS GAS
K873587 · BXK
National Welders
Anesthesiology · 56d
Cleared Oct 30, 1987
PORTABLE VENTILATOR PATIENT CIRCUIT
K873900 · BZO
Puritan Bennett Corp.
Anesthesiology · 36d
Cleared Oct 30, 1987
ULTIMETER
K873956 · LHO
Radiation Measurements, Inc.
Radiology · 32d
Cleared Oct 30, 1987
GX-MOBILE X-RAY UNIT
K873982 · IZL
Gendex Corp.
Radiology · 30d
Cleared Oct 29, 1987
COX RAPID HEAT TRANSFER STERILIZER
K872643 · KMH
Cox Sterile Products, Inc.
General Hospital · 115d
Cleared Oct 29, 1987
QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
K873011 · LAS
Quantimetrix Medical Industries
Chemistry · 86d
Cleared Oct 29, 1987
EASY-TEST SALICYLATE (SAL) #16691
K873425 · DKJ
Em Diagnostic Systems, Inc.
Chemistry · 65d
Cleared Oct 29, 1987
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
K873426 · KLP
Em Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Oct 29, 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
K873436 · DLJ
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 29, 1987
OPHTHALAS DYE OPHTHALMIC LASER
K873460 · HQF
Biophysic Medical, Inc.
Ophthalmic · 62d
Cleared Oct 29, 1987
TODD MEDICAL/SKILLED CARE PRODUCTS
K873469 · LRP
Todd Medical, Inc.
General & Plastic Surgery · 62d
Cleared Oct 29, 1987
AFFINITY TOTAL THYROXINE IMMUNIT
K873518 · KLI
Bd Becton Dickinson Vacutainer...
Chemistry · 58d
Cleared Oct 29, 1987
PERFECT SUNTANNING BED
K873589 · LEJ
Wolff System Technology Corp.
General & Plastic Surgery · 55d
Cleared Oct 29, 1987
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Oct 29, 1987
EMIT QST GENTAMICIN ASSAY
K873855 · LCD
Syva Co.
Toxicology · 37d
Cleared Oct 29, 1987
REVISED LABELING FOR SYVA OPIATE ASSAYS
K873898 · DJG
Syva Co.
Toxicology · 35d
Cleared Oct 29, 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 29, 1987
MULTICHEM ALBUMIN REAGENT S0902
K874049 · CIX
Simmler, Inc.
Chemistry · 24d
Cleared Oct 29, 1987
REVISED LABELING FOR SYVA AMPHETAMINE ASSAY
K874080 · DKZ
Syva Co.
Toxicology · 23d
Cleared Oct 29, 1987
AHH NATURAL BREAST FORM
K874279 · GBI
Pacific Prosthetics, Inc.
General & Plastic Surgery · 9d
Cleared Oct 28, 1987
MODEL SKCK STERILE KNOB COVER KIT
K870662 · BXM
Life-Tech Intl., Inc.
Anesthesiology · 251d
Cleared Oct 28, 1987
C.L.E. ACETABULAR CUP
K870922 · JDI
Protek, Inc.
Orthopedic · 239d