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
140497–140520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1987
SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
K865101 · DXG
Spectramed, Inc.
Cardiovascular · 111d
Cleared Apr 20, 1987
S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP
K870271 · KWZ
Joint Medical Products Corp.
Orthopedic · 88d
Cleared Apr 20, 1987
CARDIOTEAM
K870527 · DXH
Cardiac Network, Inc.
Cardiovascular · 70d
Cleared Apr 20, 1987
PROTHROMBIN TIME TEST
K870596 · GJS
U. S. Diagnostics, Inc.
Hematology · 69d
Cleared Apr 20, 1987
COAGULATION CONTROL, LEVEL I
K870685 · JPA
U. S. Diagnostics, Inc.
Hematology · 60d
Cleared Apr 20, 1987
COAGULATION CONTROL, LEVEL II
K870686 · JPA
U. S. Diagnostics, Inc.
Hematology · 60d
Cleared Apr 20, 1987
COAGULATION CONTROL, LEVEL III
K870687 · JPA
U. S. Diagnostics, Inc.
Hematology · 60d
Cleared Apr 20, 1987
0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.
K871101 · BXK
Matheson Gas Products, Inc.
Anesthesiology · 32d
Cleared Apr 20, 1987
O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF
K871102 · BXK
Matheson Gas Products, Inc.
Anesthesiology · 32d
Cleared Apr 20, 1987
O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P
K871103 · BXK
Matheson Gas Products, Inc.
Anesthesiology · 32d
Cleared Apr 20, 1987
PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS
K871132 · DYB
Deltec Systems, Inc.
Cardiovascular · 31d
Cleared Apr 20, 1987
MODIFIED CPREVIVER
K871147 · BTM
Augerscope, Inc.
Anesthesiology · 39d
Cleared Apr 20, 1987
I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT
K871194 · DBL
Cronus
Immunology · 27d
Cleared Apr 20, 1987
MODEL 2000W OPTION H CONFIGURATION
K871302 · BZQ
Edentec Corp.
Anesthesiology · 19d
Cleared Apr 20, 1987
DUAL SUBSTRATE ANA
K871395 · DHN
Val Tech Diagnostics, Inc.
Immunology · 13d
Cleared Apr 17, 1987
NEONATAL FEEDING KIT
K864683 · KNT
Salt Creek Medical Technologies
Gastroenterology & Urology · 136d
Cleared Apr 17, 1987
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029 · FPB
Travenol Laboratories, S.A.
General Hospital · 115d
Cleared Apr 17, 1987
FOLEY CATHETER
K870165 · KOD
Acorn Medical Products
Gastroenterology & Urology · 93d
Cleared Apr 17, 1987
HOMEPRO II VOLUMETRIC INFUSION PUMP
K870444 · FRN
American Edwards Laboratories
General Hospital · 73d
Cleared Apr 17, 1987
E-Z LOOP
K870577 · EXB
John F. Greer Co., Inc.
Gastroenterology & Urology · 66d
Cleared Apr 17, 1987
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
K870680 · FET
Medline Industries, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 17, 1987
ADG PATELLAR COMPONENT
K870702 · JWH
Buckman Co., Inc.
Orthopedic · 56d
Cleared Apr 17, 1987
THERMAL COAGULATOR
K870705 · KNS
Microvasive
Gastroenterology & Urology · 56d
Cleared Apr 17, 1987
MODIFIED CASTLE POWERCLAVE
K870975 · FLE
Castle Co.
General Hospital · 38d