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
161041–161064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1982
CONAGRAF TM DURAPATITE CONES
K820023 · LYC
Sterling Drug, Inc.
Dental · 50d
Cleared Feb 24, 1982
KREMER BLADE GAUGE
K820050 · HOE
Accutome, Inc.
Ophthalmic · 47d
Cleared Feb 24, 1982
AIRMED SMOKE EVACUATION & FILTER
K820091 · CIE
James L. Geraci & Associates, Inc.
Chemistry · 42d
Cleared Feb 24, 1982
SECURE-ON-TOUCH
K820092 · DYH
Sci-Pharm, Inc.
Dental · 42d
Cleared Feb 24, 1982
SHARPLAN 720 CO2 SURGICAL LASER
K820101 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 40d
Cleared Feb 24, 1982
SIEMENS POLYDOROS 800
K820112 · IZO
Siemens Corp.
Radiology · 40d
Cleared Feb 24, 1982
TEC-SON II
K820162 · ELC
California Technics, Inc.
Dental · 35d
Cleared Feb 24, 1982
EMPTY STERILE CARPUJECT
K820164 · FMF
Sterling Drug, Inc.
General Hospital · 35d
Cleared Feb 24, 1982
MENTOR ACTIVATOR NEUROMUSCULAR STIMU
K820168 · IPF
Mentor Corp.
Physical Medicine · 34d
Cleared Feb 24, 1982
PHONIC EAR MODEL PE 810S
K820172 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 34d
Cleared Feb 24, 1982
SYBRON/KERR CONTOUR
K820181 · EJJ
Sybron Corp.
Dental · 33d
Cleared Feb 24, 1982
SYBRON/KERR MIRROR 3
K820183 · ELW
Sybron Corp.
Dental · 33d
Cleared Feb 24, 1982
LATERAL ANGULATING FLUORO SUSPENSION
K820184 · JAA
General Electric Co.
Radiology · 33d
Cleared Feb 24, 1982
ULTRA-WET
K820216 · ELW
Buffalo Dental Mfg. Co., Inc.
Dental · 29d
Cleared Feb 24, 1982
GDC-1130
K820277 · EJT
Deringer-Ney, Inc.
Dental · 22d
Cleared Feb 24, 1982
SURGIPEEL SELF-SEAL PACKAGING SYSTEM
K820302 · FRG
Surgicot, Inc.
General Hospital · 20d
Cleared Feb 24, 1982
H-H BURR HOLE CATHETER SUPPORT
K820311 · JXG
Holter-Hausner Intl.
Neurology · 19d
Cleared Feb 24, 1982
FINGER COT
K820383 · ILH
Conco Medical Co.
Physical Medicine · 15d
Cleared Feb 24, 1982
SIEMENS POLYDOROS 800
K827064
Siemens Medical Solutions USA, Inc.
Radiology · 40d
Cleared Feb 24, 1982
LATERAL ANGULATING FLUORO SUSPENSION
K827086
General Electric Co.
Radiology · 33d
Cleared Feb 23, 1982
DADE FACTOR ASSAY REFERENCE PLASMA
K820085 · GGP
American Dade
Hematology · 42d
Cleared Feb 23, 1982
TRACH TAPE
K820099 · BTO
Stan-Pak Ent.
Anesthesiology · 41d
Cleared Feb 23, 1982
NUPRO* GEL TRAY
K820104 · KMT
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared Feb 23, 1982
BOUNDARY
K820116 · FYA
The Buckeye Cellulose Corp.
General Hospital · 36d