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
173833–173856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1977
TRI-CON TRIGLYCERIDGE REAGENTS
K761283 · JGY
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 66d
Cleared Feb 24, 1977
COMPU-PET 300
K761290 · JQW
Nuclear Medical Laboratories, Inc.
Chemistry · 65d
Cleared Feb 24, 1977
ALKALINE PHOSPHATASE (ALP)/PNPP
K761315 · CJE
Princeton Biomedix
Chemistry · 63d
Cleared Feb 24, 1977
MARCUSE TUBE CLAMPING FORCEPS, STRAIGHT
K761334 · GEN
J. Sklar Mfg. Co., Inc.
General & Plastic Surgery · 59d
Cleared Feb 24, 1977
PACEMAKER 208S
K770005 · DXY
Elema-Schonander, Inc.
Cardiovascular · 52d
Cleared Feb 24, 1977
PINLOCK CONTAINER
K770071 · KDT
Perkins Mfg. Co.
Pathology · 42d
Cleared Feb 24, 1977
DEBAKEY VASCULOUR-D PROSTHESES
K770235 · DSY
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 17d
Cleared Feb 24, 1977
CHROMATOGRAPH, SERIES 3, LIQUID
K770254 · KZR
The Perkin-Elmer Corp.
Toxicology · 14d
Cleared Feb 24, 1977
TEMPERATURE FEEDBACK SYS, MODEL DT100
K770270 · HCC
Bio-Feedback Systems, Inc.
Neurology · 13d
Cleared Feb 24, 1977
MONITOR, PORTABLE, PART #431-010
K770279 · DXJ
Mennen Greatbatch Electonics
Cardiovascular · 10d
Cleared Feb 24, 1977
WEDGE TIP, SMALL, MODEL #030-191
K770282 · DTB
Med Telectronics , Ltd.
Cardiovascular · 10d
Cleared Feb 24, 1977
WEDGE TIP, SMALL, MODEL #030-194
K770283 · DTB
Med Telectronics , Ltd.
Cardiovascular · 10d
Cleared Feb 24, 1977
BALL TIP, MODEL #030-185
K770284 · DTB
Med Telectronics , Ltd.
Cardiovascular · 10d
Cleared Feb 24, 1977
BALL TIP, MODEL #030-188
K770285 · DTB
Med Telectronics , Ltd.
Cardiovascular · 10d
Cleared Feb 24, 1977
MONITOR, PULSE WAVE VELOCITY P607
K770330 · DXG
Cyborg Corp.
Cardiovascular · 7d
Cleared Feb 24, 1977
AMPLIFIER, PHOTOPULSE, MODEL PA13
K770332 · JOM
Medsonics
Cardiovascular · 7d
Cleared Feb 24, 1977
RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO
K770365 · DPO
Travenol Laboratories, S.A.
Immunology · 1d
Cleared Feb 23, 1977
OPERATING ROOM VENTILATOR
K770084 · FZH
Dupaco, Inc.
General & Plastic Surgery · 40d
Cleared Feb 23, 1977
ELECTRONIC DEPILATORY MODEL 202
K770186 · KCX
Electronic Depilatory, Inc.
General & Plastic Surgery · 27d
Cleared Feb 23, 1977
ELECTRONIC DEPILATORY MODEL 303
K770187 · KCX
Electronic Depilatory, Inc.
General & Plastic Surgery · 27d
Cleared Feb 23, 1977
GO/HPO-GLUCOSE REAGENT (TRINDER)
K770200 · CGA
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Feb 23, 1977
HEAVY FOAM HEEL & ELBOW PROTECTORS
K770223 · IPM
Robert R. Moore
Physical Medicine · 20d
Cleared Feb 23, 1977
GLUCOSE (HEXOKINASE) DELTA TEST ASSAY
K770262 · CFR
Bd Becton Dickinson Vacutainer...
Chemistry · 12d
Cleared Feb 23, 1977
LDH-L TEST
K770267 · CFJ
Sclavo, Inc.
Chemistry · 12d