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
160129–160152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1982
DIGITAL BLOOD PRESSURE METER
K821437 · DXN
Timex Medical Products Corp.
Cardiovascular · 15d
Cleared May 28, 1982
DURAZYME CPK
K821452
American Monitor Corp.
Chemistry · 14d
Cleared May 28, 1982
ULTRAZYME PLUS AMYL #65031&64982
K821459 · JFJ
Emd Chemicals, Inc.
Chemistry · 10d
Cleared May 28, 1982
ELECATH PORTAL VEIN/BILIARY DRAIN ASSM
K821488 · KNN
Electro-Catheter Corp.
Physical Medicine · 10d
Cleared May 28, 1982
TRACKER-2 CHANNEL ECG TAPE RECORDER
K821516 · DSH
Reynolds Medical , Ltd.
Cardiovascular · 7d
Cleared May 28, 1982
SYRINGE IRRIGATING
K821530 · KYZ
Medcare Disp Products, Inc.
General Hospital · 7d
Cleared May 28, 1982
HENKE DISPOSABLE SYRINGE
K821537 · FMF
C. B. Dumont Company, Inc.
General Hospital · 4d
Cleared May 27, 1982
BARD CONTOUR LINK S.K.I. KNEE SYS
K820002 · HRY
C.R. Bard, Inc.
Orthopedic · 143d
Cleared May 27, 1982
FAST VIOLET B
K821038 · JTS
Dms Laboratories
Microbiology · 44d
Cleared May 27, 1982
PNEUMO DRAIN T.M. RECORDER #PD-800
K821160 · GCX
Sugen Industries, Inc.
General Hospital · 35d
Cleared May 27, 1982
MEDCO CUSTOM EAR PROTECTOR MOLD KIT
K821187 · EWD
Santa Barbara Medco, Inc.
Ear, Nose, Throat · 30d
Cleared May 27, 1982
THUMB DRESSING FORCEPS
K821267 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
TRACHEOSTOMY CARE TRAYS
K821269 · EQN
Intermed, Inc.
Ear, Nose, Throat · 24d
Cleared May 27, 1982
HALSTEAD MOSQUITO FORCEPS
K821274 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
KELLY FORCEPS CURVED 5 1/2
K821277 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
HARTMAN FORCEPS STRAIGHT 3 1/2
K821278 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
HALSTEAD FORCEPS (MOSQUITO) 5
K821279 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
TISSUE FORCEPS
K821280 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
CRILE, CURVED FORCEPS 5 1/2
K821281 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
HARTMAN FORCEPS (MOSQUITO)
K821283 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
CRILE FORCEPS STRAIGHT 5 1/2
K821287 · GEN
Conphar, Inc.
General & Plastic Surgery · 23d
Cleared May 27, 1982
ROCHESTER PEAN FORCEPS CURVED 6 1/4
K821296 · GEN
Conphar, Inc.
General & Plastic Surgery · 23d
Cleared May 27, 1982
DUSTCOVERS &/OR STERILITY MAINT. COVERS
K821332 · KCT
Medical Industries Packaging, Inc.
General Hospital · 23d
Cleared May 27, 1982
SALMONELLA POLY
K821339 · GEN
Analytical Products, Inc.
Microbiology · 22d