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
164353–164376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1981
TELEMETRY PACEMAKER MONITOR
K802357 · DRG
Intermedics, Inc.
Cardiovascular · 139d
Cleared Feb 12, 1981
SEARLE VASCULAR LOOPS
K802485 · KDC
G.D. Searle and Co.
General & Plastic Surgery · 125d
Cleared Feb 12, 1981
ELECTROSURGICAL TIP CLEANER & HOLDER
K803055 · GEI
Devon Industries, Inc.
General & Plastic Surgery · 72d
Cleared Feb 12, 1981
DISPOSABLE BAG MASK ADEJUNCT
K803066 · BTM
T. S. Enterprises, Inc.
Anesthesiology · 70d
Cleared Feb 12, 1981
AGINSKY NAIL
K803106 · HSB
Cintor Orthopaedic Div.
Orthopedic · 65d
Cleared Feb 12, 1981
TASSAWAY
K803250 · HHE
Plastic Applications, Inc.
Obstetrics & Gynecology · 51d
Cleared Feb 12, 1981
ACRIDINE ORANGE STAIN
K803304 · IDC
Remel Co.
Microbiology · 44d
Cleared Feb 12, 1981
REPLACABLE BATTERY HI-TEMP CAUTERY
K810014 · HAM
Medical Products Development, Inc.
General & Plastic Surgery · 38d
Cleared Feb 12, 1981
MULTIHI-TEMP CAUTERY
K810015 · HAM
Medical Products Development, Inc.
General & Plastic Surgery · 38d
Cleared Feb 12, 1981
ACRIDINE ORANGE STAIN
K810040 · IDC
Bd Becton Dickinson Vacutainer...
Chemistry · 34d
Cleared Feb 12, 1981
I.M. RETROGRADE BLADES
K810045 · GFA
Hogan & Hartson
General & Plastic Surgery · 35d
Cleared Feb 12, 1981
STERILE SILICONE TUBING
K810071 · GBS
Medspec Corp.
General & Plastic Surgery · 30d
Cleared Feb 12, 1981
105MM ROLL FILM FLUOROGR. CAMERA, #105
K810072 · IZJ
Scientex Corp.
Radiology · 30d
Cleared Feb 12, 1981
MOTI APRON
K810095 · KPY
Moti Enterprises, Inc.
Radiology · 29d
Cleared Feb 12, 1981
BREAST PUMP
K810100 · HGY
American Hospital Supply Corp.
Obstetrics & Gynecology · 29d
Cleared Feb 12, 1981
DUAL-PHOTON TOTAL BODY BONE MINERAL ANA
K810140 · KGI
Lunar Radiation Corp.
Radiology · 22d
Cleared Feb 12, 1981
OMNISURG WORKING INSTRUMENT TABLE
K810150
Polamedco, Inc.
General & Plastic Surgery · 22d
Cleared Feb 12, 1981
SLICK SET W/SURELOC EXTERNAL CONNECTOR
K810151 · BTR
Polamedco, Inc.
Anesthesiology · 22d
Cleared Feb 12, 1981
BONE MINERAL ANALYZER CONTROLLER
K810159 · KGI
Lunar Radiation Corp.
Radiology · 22d
Cleared Feb 12, 1981
BLADE SAFE
K810208 · MMK
Instranetics, Inc.
General Hospital · 17d
Cleared Feb 12, 1981
CRYSTAL-BOND
K810241 · DYH
American Ormco
Dental · 15d
Cleared Feb 12, 1981
SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME
K810243 · BZC
Cardio Pulmonary Instruments
Anesthesiology · 15d
Cleared Feb 12, 1981
MEAN PRESSURE MONITOR
K810255 · CAP
Healthdyne, Inc.
Anesthesiology · 13d
Cleared Feb 12, 1981
GRAB BARS
K810275 · IKX
Maddak, Inc.
Physical Medicine · 10d