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

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175,820 results
133513–133536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1988
DC-1 I.V. DOSAGE COMPUTER
K884016 · NDC
Phase Medical, Inc.
General Hospital · 89d
Cleared Dec 20, 1988
ERA 2000 EMERGENCY RESUSCITATOR
K884089 · BTL
Neotronics Medical , Ltd.
Anesthesiology · 83d
Cleared Dec 20, 1988
TURBOX ANTITHROMBIN III
K884144 · JBQ
Unipath , Ltd.
Hematology · 81d
Cleared Dec 20, 1988
TURBOX FIBRINOGEN
K884179 · KQJ
Unipath , Ltd.
Hematology · 81d
Cleared Dec 20, 1988
VOXELSCOPE(TM)
K884268 · JAK
Dynamic Digital Displays, Inc.
Radiology · 70d
Cleared Dec 20, 1988
KOTEX STICK TAMPONS, REGULAR AND SUPER
K884305 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 68d
Cleared Dec 20, 1988
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317 · JAA
Medrad, Inc.
Radiology · 68d
Cleared Dec 20, 1988
UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.
K884359 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 64d
Cleared Dec 20, 1988
MAXITHINS SUPER PADS, DEODORANT
K884446 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 60d
Cleared Dec 20, 1988
ROCKET INTRAUTERINE DEPTH SOUND
K884684 · HHM
A & A Medical, Inc.
Obstetrics & Gynecology · 42d
Cleared Dec 20, 1988
MODIFIED 10CC SYRINGE CONTROL RING SET
K884985 · FMF
Procedure Products, Inc.
General Hospital · 19d
Cleared Dec 20, 1988
QM300 PCR ANTIBODY PACK
K885001 · DCN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Dec 19, 1988
CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.
K883488 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 125d
Cleared Dec 19, 1988
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
K883530 · CEP
Tambrands, Inc.
Chemistry · 123d
Cleared Dec 19, 1988
INTRAVASCULAR ADMINISTRATION SET
K883764 · FPA
Device Labs, Inc.
General Hospital · 104d
Cleared Dec 19, 1988
DOUBLE CLOSED URINARY DRAINAGE SYSTEM
K883886 · FCN
Knight Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 19, 1988
MODIFIED IMED GEMINI PC-1 INFUSION PUMP
K883993 · FRN
Imed Corp.
General Hospital · 90d
Cleared Dec 19, 1988
GONIOMETER AND BIOMEDICAL RECORDER SYSTEM
K884003 · KQX
Penny & Giles Blackwood , Ltd.
Neurology · 89d
Cleared Dec 19, 1988
HEARING AID WIDEX BTE
K884113 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 81d
Cleared Dec 19, 1988
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE
K884459 · GEX
Luxar Corp.
General & Plastic Surgery · 56d
Cleared Dec 19, 1988
CREATININE TEST (CREA) ITEM #65663
K884734 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Dec 16, 1988
MRL PACETTE, 450SLL
K880932 · DRO
Medical Research Laboratories, Inc.
Cardiovascular · 284d
Cleared Dec 16, 1988
AIRWAY-CIRCULATION EVALUATOR
K881483 · BTM
Resuscitation Ace, Inc.
Anesthesiology · 252d
Cleared Dec 16, 1988
EZ-SCREEN CANNABINOID/COCAINE
K883105 · DIO
Environmental Diagnostics, Inc.
Toxicology · 144d