FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92209–92232 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1997
GALILEO HIGH RESOLUTION MICRO COUPLER
K971896 · HET
Netoptix Corp.
Obstetrics & Gynecology · 141d
Cleared Oct 10, 1997
ACCUMETER THEOPHYLLINE TEST
K972495 · KLS
Chemtrak, Inc.
Toxicology · 99d
Cleared Oct 10, 1997
PLATALLOY
K972607 · EJH
Aalba Dent, Inc.
Dental · 91d
Cleared Oct 10, 1997
STORZ MILLENNIUM VISCOUS FLUID SYSTEM
K972664 · MRH
Storz Instrument Co.
Ophthalmic · 86d
Cleared Oct 10, 1997
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM
K972684 · DYB
Innerdyne, Inc.
Cardiovascular · 85d
Cleared Oct 10, 1997
CBALK-1000 BLADE
K972727 · HNO
Howard Instruments, Inc.
Ophthalmic · 81d
Cleared Oct 10, 1997
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
K972796 · GJS
Sigma Diagnostics, Inc.
Hematology · 74d
Cleared Oct 10, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972799 · LTT
Dade Microscan, Inc.
Microbiology · 74d
Cleared Oct 10, 1997
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
K972823 · MFD
A & A Medical, Inc.
Obstetrics & Gynecology · 72d
Cleared Oct 10, 1997
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
K972964 · KOE
Atrion Medical Products, Inc.
Gastroenterology & Urology · 60d
Cleared Oct 10, 1997
INSULATOR WIRE GUIDE
K972977 · KNY
Cook Urological, Inc.
Gastroenterology & Urology · 60d
Cleared Oct 10, 1997
ELECSYS DIGOXIN
K973112 · KXT
Boehringer Mannheim Corp.
Toxicology · 51d
Cleared Oct 10, 1997
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
K973157 · JQB
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Oct 10, 1997
LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973488 · JTN
Oxoid , Ltd.
Microbiology · 25d
Cleared Oct 10, 1997
LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973489 · JTN
Oxoid , Ltd.
Microbiology · 25d
Cleared Oct 10, 1997
LUBRIGLIDE
K973557 · KMJ
Qualis, Inc.
General Hospital · 21d
Cleared Oct 09, 1997
MRI COMPATIBLE BIOPSY NEEDLES
K962977 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 435d
Cleared Oct 09, 1997
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
K964434 · IPF
Skylark Device Co., Ltd.
Physical Medicine · 338d
Cleared Oct 09, 1997
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
K971281 · DQX
Medcomp
Cardiovascular · 185d
Cleared Oct 09, 1997
CRE BALLOON DILATATION CATHETER
K971320 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 182d
Cleared Oct 09, 1997
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858 · KQJ
Sigma Diagnostics, Inc.
Hematology · 142d
Cleared Oct 09, 1997
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED:...
K972130 · IZJ
Fairmontmedical
Radiology · 125d
Cleared Oct 09, 1997
STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K972622 · MBI
Influence, Inc.
Orthopedic · 87d
Cleared Oct 09, 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629 · KTT
Depuy, Inc.
Orthopedic · 87d