FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
139897–139920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1987
BIOCHEM 8090 CAPNOGRAPH
K871133 · CCK
Biochem International, Inc.
Anesthesiology · 32d
Cleared Apr 21, 1987
M-10 VENTILATION MONITOR
K871139 · CAP
Bio-Med Devices, Inc.
Anesthesiology · 29d
Cleared Apr 21, 1987
C.P.A.P. NASAL CANNULA
K871157 · BZD
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 28d
Cleared Apr 21, 1987
CUFFED TRACHEAL TUBE (MULTIPLE)
K871204 · BTR
Mallinckrodt Critical Care
Anesthesiology · 27d
Cleared Apr 21, 1987
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
K871346 · CZW
Dako Corp.
Immunology · 15d
Cleared Apr 21, 1987
KULTSURE
K871404 · JSM
Ncs Diagnostics, Inc.
Microbiology · 13d
Cleared Apr 20, 1987
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
K864006 · LHL
Medical Diagnostic Technologies, Inc.
Microbiology · 187d
Cleared Apr 20, 1987
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA
K864597 · LQF
Gen-Probe, Inc.
Microbiology · 147d
Cleared Apr 20, 1987
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K864998 · JSM
Boots-Celltech Diagnostics, Inc.
Microbiology · 119d
Cleared Apr 20, 1987
ARTHROFLATOR
K865066 · HRX
F.M. Wiest USA, Inc.
Orthopedic · 117d
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