FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
100633–100656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1995
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
K954579 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 67d
Cleared Dec 08, 1995
PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
K954750 · BTR
Unomedical Sdn Bhd
Anesthesiology · 53d
Cleared Dec 08, 1995
SILICONE ENDOTRACHEAL TUBE
K954751 · BTR
Unomedical Sdn Bhd
Anesthesiology · 53d
Cleared Dec 08, 1995
PEDIATRIC SILICONE ENDOTRACHEAL TUBE
K954753 · BTR
Unomedical Sdn Bhd
Anesthesiology · 53d
Cleared Dec 08, 1995
WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
K954754 · BTR
Unomedical Sdn Bhd
Anesthesiology · 53d
Cleared Dec 08, 1995
CANNULOC THREADED CANNULA
K955273 · HRX
Linvatec Corp.
Orthopedic · 23d
Cleared Dec 08, 1995
RACE CAR TYMPANOMETER
K955289 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 22d
Cleared Dec 08, 1995
VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM
K955346 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 17d
Cleared Dec 08, 1995
KOH MICRO-SUTURING INSTRUMENTS
K955479 · OCW
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 8d
Cleared Dec 07, 1995
CHROM Z-PLASMINOGEN, CAT. NO. 5244
K952669 · GGP
Helena Laboratories
Hematology · 178d
Cleared Dec 07, 1995
ACS TOURGIDE GUIDING CATHETER
K953987 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 106d
Cleared Dec 07, 1995
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K954582 · DSY
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared Dec 06, 1995
PROTECTRODE SYSTEM
K926094 · GXZ
The Electrode Store, Inc.
Neurology · 1099d
Cleared Dec 06, 1995
J TONGS
K930021 · HAX
Jerome Medical
Neurology · 1065d
Cleared Dec 06, 1995
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
K934014 · LRJ
Biotrol, USA, Inc.
General Hospital · 841d
Cleared Dec 06, 1995
BIOCIDE CLEANER/DISINFECTANT
K934150 · LRJ
Juan Sierra
General Hospital · 833d
Cleared Dec 06, 1995
LATEX CONDOM
K941258 · HIS
Suretex, Ltd.
Obstetrics & Gynecology · 630d
Cleared Dec 06, 1995
MAYFIELD CHILD DISPOSABLE SKULL PIN
K941558 · HBL
Ohio Medical Instrument Co., Inc.
Neurology · 615d
Cleared Dec 06, 1995
RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND...
K944786 · HIS
Line One Laboratories & Trading Co.
Obstetrics & Gynecology · 434d
Cleared Dec 06, 1995
CHEMMATE(TM) LAMBDA
K950149 · DEH
Biotek Solutions, Inc.
Immunology · 323d
Cleared Dec 06, 1995
UNIQUE NEEDLE
K950245 · FMF
Unique Management Ent., Inc.
General Hospital · 320d
Cleared Dec 06, 1995
INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE
K952688 · HIR
Empi
Gastroenterology & Urology · 177d
Cleared Dec 06, 1995
EMG DISC RECORDING ELECTRODE WITH PIN
K952690 · GXY
Chalgren Enterprises, Inc.
Neurology · 177d
Cleared Dec 06, 1995
EMG DISC RECORDING ELECTRODE WITH PIN
K952908 · GXY
Chalgren Enterprises, Inc.
Neurology · 166d