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
86593–86616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1999
ACIST INJECTOR SYSTEM, MODEL CL100 H
K984058 · IZQ
Acist Medical Systems
Cardiovascular · 90d
Cleared Feb 11, 1999
APF POROUS COATED LINE EXTENSION
K984154 · JDI
Biomet, Inc.
Orthopedic · 84d
Cleared Feb 11, 1999
WELCH ALLYN FRONT-LINE DOC
K984215 · LLZ
Welch Allyn, Inc.
Radiology · 79d
Cleared Feb 11, 1999
NEUROVASX SUB-MICROINFUSION CATHETER
K984258 · DQO
Neuro Vasx, Inc.
Cardiovascular · 73d
Cleared Feb 11, 1999
INFINITY GLUCOSE REAGENT
K984574 · CFR
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 11, 1999
SMOOTHLASE ALEXANDRITE LASER SYSTEM
K990043 · GEX
Leisegang Medical, Inc.
General & Plastic Surgery · 36d
Cleared Feb 11, 1999
LOBOB UNIVERSAL CONTACT LENS CLEANER
K990044 · LPN
Lobob Laboratories, Inc.
Ophthalmic · 36d
Cleared Feb 11, 1999
VENTLAB VERIFY II
K990098 · BTR
Ventlab Corp.
Anesthesiology · 30d
Cleared Feb 10, 1999
POTENCY TEST STRIPS, INDICATOR TEST STRIPS
K974426 · LIF
Reprocessing Products Corp
Gastroenterology & Urology · 471d
Cleared Feb 10, 1999
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER
K983054 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 162d
Cleared Feb 10, 1999
AUTO SUTURE SITE MARKER CLIP
K983400 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 135d
Cleared Feb 10, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
K983704 · JCM
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Feb 10, 1999
CARE TENS
K984025 · GZJ
Care Rehab, Inc.
Neurology · 90d
Cleared Feb 10, 1999
VIPERSOFT
K984030 · EHD
Integra Medical
Radiology · 90d
Cleared Feb 10, 1999
INNOVA TELESCOPIC DISTRACTOR
K984117 · MQN
Innova Corp.
Dental · 85d
Cleared Feb 10, 1999
AARON ESU FOOT-CONTROL ADAPTER #A1205A
K984236 · GEI
Aaron Medical Industries
General & Plastic Surgery · 77d
Cleared Feb 10, 1999
SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z,...
K984239 · GEI
Aaron Medical Industries
General & Plastic Surgery · 75d
Cleared Feb 10, 1999
MODIFICATION OF BIONECT HYDROGEL GAUZE PADS
K984262 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 85d
Cleared Feb 10, 1999
MODIFICATION OF BIONECT CLEAR HYDROGEL
K984264 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 85d
Cleared Feb 10, 1999
MODIFICATION OF BIONECT HYDROGEL SPRAY
K984266 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 85d
Cleared Feb 10, 1999
MODIFICATION OF BIONECT HYDROGEL FOAM
K984267 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 85d
Cleared Feb 10, 1999
DISPOSABLE ELECTROSURGERY GROUNDING PAD
K984276 · GEI
E & M Engineering, Inc.
General & Plastic Surgery · 72d
Cleared Feb 10, 1999
BIONECT HYDROGEL
K984413 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 85d
Cleared Feb 10, 1999
SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE
K990088 · GAT
Aesculap, Inc.
General & Plastic Surgery · 30d