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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
108673–108696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1994
INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR
K940428 · GCJ
Innerdyne Medical, Inc.
General & Plastic Surgery · 84d
Cleared Apr 25, 1994
GUANGZHOU DASHIN OPTICS ENT.
K940946 · HQY
Guangzhou Dashin Optics Enterprise ,...
Ophthalmic · 56d
Cleared Apr 22, 1994
OPTIONS COMFORT CURVES CLOTH MENSTRUAL PAD SYSTEM
K922911 · HHD
Feminine Options
Obstetrics & Gynecology · 674d
Cleared Apr 22, 1994
MEMORY WIRE
K923372 · EJF
Althan, Inc.
Dental · 652d
Cleared Apr 22, 1994
CUSTOM SYRIGENE KITS
K925822 · FMF
Syrigene Medical Technologies, Inc.
General Hospital · 521d
Cleared Apr 22, 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795 · GXZ
Cadwell Laboratories, Inc.
Neurology · 261d
Cleared Apr 22, 1994
NU-PREP GEL
K933798 · GXB
Cadwell Laboratories, Inc.
Neurology · 261d
Cleared Apr 22, 1994
MONOPOLAR EMG NEEDLE ELECTRODE
K933806 · GXZ
Cadwell Laboratories, Inc.
Neurology · 261d
Cleared Apr 22, 1994
KARL STORZ XENON LIGHT SOURCE MODEL 201320-20
K934559 · GCT
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 218d
Cleared Apr 22, 1994
X-RAY GRID (RADIOLOGICAL GRID)
K940309 · IXJ
J.P.I. Chicago Co.
Radiology · 88d
Cleared Apr 22, 1994
COMPEL SURGICAL GOWNS
K940758 · FYA
Standard Textile Co., Inc.
General Hospital · 63d
Cleared Apr 22, 1994
SAFETEX HYPOALLERGENIC POWDERFREE LATEX EXAMINATION GLOVE
K940873 · LYY
Aladan Corp.
General Hospital · 56d
Cleared Apr 22, 1994
PRODIGIT 2000
K940999 · EWO
Calmed Technology, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 22, 1994
BRIMFIELD PRECISION FAN RETRACTOR
K941316 · GCJ
Springfield Surgical Instruments
General & Plastic Surgery · 35d
Cleared Apr 22, 1994
MPI DENTURE ADHESIVE FILM SEALS
K941365 · KOT
Medical Polymers, Inc.
Dental · 32d
Cleared Apr 22, 1994
OPERATING MICROSCOPE AA OM 10
K941399 · FSO
Appasamy Associates (U.S.A.), Inc.
General & Plastic Surgery · 31d
Cleared Apr 22, 1994
SUTURE REMOVAL KIT
K941465 · MCZ
Clinical Resources, Inc.
General & Plastic Surgery · 25d
Cleared Apr 22, 1994
SURGICAL INSTRUMENTS KIT
K941466 · FRG
Clinical Resources, Inc.
General Hospital · 25d
Cleared Apr 22, 1994
ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS
K941494 · HET
Sharpe Endosurgical Corp.
Obstetrics & Gynecology · 25d
Cleared Apr 21, 1994
INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION
K922154 · HIB
Olsen Electrosurgical, Inc.
Obstetrics & Gynecology · 714d
Cleared Apr 21, 1994
FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
K924892 · DAT
Organon Teknika Corp.
Hematology · 569d
Cleared Apr 21, 1994
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
K925493 · GJA
Biomerieux Vitek, Inc.
Hematology · 535d
Cleared Apr 21, 1994
QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
K931756 · GGT
R&D Systems, Inc.
Hematology · 378d
Cleared Apr 21, 1994
JARIT SURGICAL INSTRUMENTS
K932456 · KNF
J. Jamner Surgical Instruments, Inc.
Obstetrics & Gynecology · 335d