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
138145–138168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1987
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
K872166 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 117d
Cleared Sep 30, 1987
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 111d
Cleared Sep 30, 1987
SURE-STREP A TEST KIT CATALOG NO. MB-1083
K872346 · GTZ
Medix Biotech, Inc.
Microbiology · 105d
Cleared Sep 30, 1987
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
K872596 · DRS
American Edwards Laboratories
Cardiovascular · 90d
Cleared Sep 30, 1987
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K872652 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 85d
Cleared Sep 30, 1987
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
K872719 · DTN
Shiley, Inc.
Cardiovascular · 82d
Cleared Sep 30, 1987
OXFORD RETRO-ILLUMINATION CATARACT CAMERA
K873157 · HKI
Holofax , Ltd.
Ophthalmic · 51d
Cleared Sep 30, 1987
URETERAL BULB DILATORS
K873178 · EZN
Penn Medical Devices, Inc.
Gastroenterology & Urology · 49d
Cleared Sep 30, 1987
MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
K873206 · DTW
Respiratory Support Products, Inc.
Cardiovascular · 47d
Cleared Sep 30, 1987
OVAL PULL-APART SHEATH/DILATOR
K873394 · DYB
Quinton, Inc.
Cardiovascular · 37d
Cleared Sep 30, 1987
A.R.M. (ASPEN RETURN MONITOR)
K873591 · GEI
Qmed, Inc.
General & Plastic Surgery · 26d
Cleared Sep 30, 1987
TENS LEAD
K873608 · GZI
Desco Industries, Inc.
Neurology · 22d
Cleared Sep 30, 1987
NONPRESCRIPTION SUNGLASSES
K873685 · HQY
Arcotoys, Inc.
Ophthalmic · 16d
Cleared Sep 30, 1987
LEUKOCLIP(R)
K873744 · FZQ
Beiersdorf, Inc.
General & Plastic Surgery · 14d
Cleared Sep 29, 1987
ADMS TRANSRECTAL 7.5 MHZ PROBE
K870967 · ITX
Diasonics, Inc.
Radiology · 203d
Cleared Sep 29, 1987
ARTHRO AUTOMAT 5002
K871180 · HRX
F.M. Wiest USA, Inc.
Orthopedic · 188d
Cleared Sep 29, 1987
ARTHROCOMBI 5003
K871181 · HRX
F.M. Wiest USA, Inc.
Orthopedic · 188d
Cleared Sep 29, 1987
G-GT STANDARD CALIBRATOR
K871759 · JIT
Wako Chemicals USA, Inc.
Chemistry · 147d
Cleared Sep 29, 1987
SPINOSCOPE
K872836 · IKN
Diagnospine Fabrication, Inc.
Neurology · 74d
Cleared Sep 29, 1987
EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
K872852 · LCP
Sandare Chemical Co., Inc.
Hematology · 71d
Cleared Sep 29, 1987
QTEST STREP
K872961 · GTZ
Quidel Corp.
Microbiology · 62d
Cleared Sep 29, 1987
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K873171 · JHX
American Dade
Chemistry · 49d
Cleared Sep 29, 1987
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
K873186 · CEP
Serono Diagnostics, Inc.
Chemistry · 48d
Cleared Sep 29, 1987
TELSTAR MODEL PP
K873210 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 46d