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
81889–81912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2000
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
K994274 · FRN
Quest Medical, Inc.
General Hospital · 163d
Cleared May 30, 2000
NEOCARE 20 MICRON BLOOD FILTER
K000719 · CAK
Whatman, Inc.
General Hospital · 88d
Cleared May 30, 2000
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR...
K000720 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 88d
Cleared May 30, 2000
PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
K001108 · EBF
Prime Dental Manufacturing, Inc.
Dental · 55d
Cleared May 30, 2000
EAGLE ENDO SPECIMEN RETRIEVAL BAG
K001264 · GCJ
Eagle Endoscopic, Inc.
General & Plastic Surgery · 41d
Cleared May 30, 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE...
K001302 · GEI
Arthrocare Corp.
General & Plastic Surgery · 36d
Cleared May 30, 2000
SOVEREIGN BIPOLAR INSTRUMENTS
K001330 · GEI
Aesculap, Inc.
General & Plastic Surgery · 33d
Cleared May 30, 2000
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K993010 · CBF
Environmental Tectonics Corp.
Anesthesiology · 266d
Cleared May 30, 2000
HM-930 ELECTROSURGICAL UNIT
K993991 · GEI
Hill-Med, Inc.
General & Plastic Surgery · 188d
Cleared May 26, 2000
SWIVEL ELBOW
K000215 · BZD
Engineered Medical Systems
Anesthesiology · 123d
Cleared May 26, 2000
DINAMAP ADVANCED NIBP MODULE
K000500 · DXN
Critikon Company, LLC
Cardiovascular · 102d
Cleared May 26, 2000
MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
K000669 · GCJ
Medivision Endoscopy
General & Plastic Surgery · 88d
Cleared May 26, 2000
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
K000673 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 88d
Cleared May 26, 2000
WHEELCHAIR, MODELS H001A, 4422
K000738 · IOR
Jackson Company, LLC
Physical Medicine · 80d
Cleared May 26, 2000
RIGID GAS PERMEABLE CONTACT LENS
K000795 · HQD
Polymer Technology
Ophthalmic · 74d
Cleared May 26, 2000
SPIRAL IMAGING OPTION
K000802 · LNH
GE Medical Systems
Radiology · 74d
Cleared May 26, 2000
BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900
K000960 · IYO
Barzell-Whitmore Maroon Bells, Inc.
Radiology · 63d
Cleared May 26, 2000
BEHRING COAGULATION SYSTEM (BCS)
K000973 · JPA
Dade Behring, Inc.
Hematology · 60d
Cleared May 26, 2000
LIBERTY 9000 BREAST COIL
K000993 · MOS
Usa Instruments, Inc.
Radiology · 59d
Cleared May 26, 2000
OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K001203 · ITX
The Olympus Optical Co.
Radiology · 43d
Cleared May 26, 2000
SURGITRON IEC II
K001253 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 37d
Cleared May 26, 2000
MODIFICATION TO KION ANESTHESIA SYSTEM
K001315 · BSZ
Siemens Elema AB
Anesthesiology · 30d
Cleared May 26, 2000
QUICKSCREEN PRO DRUG CUP, MODEL 9195X
K001397 · DKZ
Phamatech
Toxicology · 23d
Cleared May 26, 2000
OPTIMUM WETTING AND REWETTING DROP
K001428 · MRC
Lobob Laboratories, Inc.
Ophthalmic · 21d