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
85657–85680 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1999
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
K991609 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 71d
Cleared Jul 20, 1999
ELEKTA STEREOTACTIC GUIDE
K991636 · HAW
Elekta Instrument AB
Neurology · 69d
Cleared Jul 20, 1999
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860 · GXN
Synthes (Usa)
Neurology · 49d
Cleared Jul 20, 1999
Q-LITE 75 LIGHT CURE UNIT
K991865 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 49d
Cleared Jul 20, 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · MDA
Smith & Nephew, Inc.
General & Plastic Surgery · 40d
Cleared Jul 20, 1999
SYNTHES CRANIAL FLAP TUBE CLAMP
K992000 · GXN
Synthes (Usa)
Neurology · 35d
Cleared Jul 19, 1999
SUMMER'S EVE LUBRICATING JELLY
K990597 · HIS
C.B. Fleet Co., Inc.
Obstetrics & Gynecology · 145d
Cleared Jul 19, 1999
MICROTOOLS
K991104 · MQH
Conception Technology, Inc.
Obstetrics & Gynecology · 109d
Cleared Jul 19, 1999
FERTILIZATION MEDIA-HTF
K991173 · MQL
Intl., Inc.
Obstetrics & Gynecology · 103d
Cleared Jul 19, 1999
MEDITRON STETHOSCOPE SYSTEM
K991367 · DQD
Meditron AS
Cardiovascular · 90d
Cleared Jul 19, 1999
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
K991408 · MQG
Thermoquest Corp.
Obstetrics & Gynecology · 88d
Cleared Jul 19, 1999
MR SPECTROSCOPY PACKAGE
K991568 · LNI
Philips Medical Systems (Cleveland),...
Radiology · 75d
Cleared Jul 19, 1999
SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES
K991700 · MQH
Swemed Lab International AB
Obstetrics & Gynecology · 62d
Cleared Jul 19, 1999
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102,...
K991827 · HIB
Ri Mos. S.R.L.
Obstetrics & Gynecology · 52d
Cleared Jul 19, 1999
CUTE-LITE I LIGHT CURE UNIT
K991863 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 48d
Cleared Jul 16, 1999
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K991403 · LPN
Ciba Vision Corporation
Ophthalmic · 85d
Cleared Jul 16, 1999
GEBAUER'S CHLORIDE FINE NOZZE
K991514 · MLY
Gebauer Co.
Physical Medicine · 77d
Cleared Jul 16, 1999
STAT PROFILE M7 ANALYZER
K991727 · CGL
Nova Biomedical Corp.
Chemistry · 57d
Cleared Jul 15, 1999
EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
K983940 · DYB
Adam Spence Corp.
Cardiovascular · 252d
Cleared Jul 15, 1999
PARKER FLEX-TIP TRACHEAL TUBE
K984528 · BTR
Parker Medical Assoc.
Anesthesiology · 206d
Cleared Jul 15, 1999
MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM
K990304 · DZE
Astra Tech, Inc.
Dental · 164d
Cleared Jul 15, 1999
E9000 SYSTEM
K990524 · HRX
Linvatec Corp.
Orthopedic · 146d
Cleared Jul 15, 1999
DBSET MULTIDRUG SCREEN TEST KIT
K990681 · DKZ
Ameritek, Inc.
Toxicology · 135d
Cleared Jul 15, 1999
RAPIDONE - OPIATES TEST
K990820 · DJG
American Bio Medica Corp.
Toxicology · 126d