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
91705–91728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 09, 1997
DUAL OFFSET PERFECTA IMC HIP STEM
K972641 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Oct 09, 1997
GAMMA LOCKING NAIL SYSTEM
K972813 · HSB
Howmedica Corp.
Orthopedic · 72d
Cleared Oct 09, 1997
GLUCOTREND BASIC SYSTEM
K972876 · LFR
Boehringer Mannheim Corp.
Chemistry · 66d
Cleared Oct 09, 1997
MULTITAK SS SUTURE SYSTEM
K973015 · MBI
Bonutti Research
Orthopedic · 57d
Cleared Oct 09, 1997
TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE
K973062 · EFA
Medidenta Intl., Inc.
Dental · 52d
Cleared Oct 09, 1997
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK...
K973075 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Oct 09, 1997
MAGO AUTOMATED EIA PROCESSOR
K973177 · JJF
Diamedix Corp.
Chemistry · 45d
Cleared Oct 09, 1997
UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
K973418 · IOR
Assembly Required Dist., Inc.
Physical Medicine · 29d
Cleared Oct 08, 1997
MD100 & MM150
K963913 · EAM
Konica Medical Corp.
Radiology · 373d