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
112321–112344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1993
NT4-PLUS
K932596 · IPF
Bmr Ent., Inc.
Physical Medicine · 76d
Cleared Aug 11, 1993
URESIL ABSCESS DRIANAGE AND IRRIGATION SET
K925117 · GBX
Uresil Corp.
General & Plastic Surgery · 306d
Cleared Aug 11, 1993
EXEL HUBER INFUSION SET ROTATING WING
K926119 · FPA
Exel Intl.
General Hospital · 251d
Cleared Aug 11, 1993
ULTRATONE 8+ & 20
K926410 · IPF
Bowater Research, Inc.
Physical Medicine · 233d
Cleared Aug 11, 1993
STAODYN EMS+2
K926510 · IPF
Staodyne, Inc.
Physical Medicine · 224d
Cleared Aug 11, 1993
OBGRIP AND UNITIPS(TM)
K930617 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 184d
Cleared Aug 11, 1993
MIST FORCEPS/CLAMPS FOR LAPAROSCOPOIC/ENDOSCOPIC
K931273 · GCJ
Minimally Invasive Surgical...
General & Plastic Surgery · 156d
Cleared Aug 11, 1993
HISTOFREEZER
K931299 · GEH
Solarcare Technologies Corp,Inc.
General & Plastic Surgery · 149d
Cleared Aug 11, 1993
POOLE TIP SUCTION PROBE
K931950 · GCY
Mayaguez Medical Center
General & Plastic Surgery · 113d
Cleared Aug 11, 1993
THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)
K932399 · IPF
Myo/Kinetic Systems, Inc.
Physical Medicine · 85d
Cleared Aug 11, 1993
DR. FOG
K932449 · OCT
O.R. Concepts, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 11, 1993
SCIMED 6F ANGIOGRAPHIC CATHETER
K932542 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Aug 11, 1993
POOLE TIP SUCTION PROBE & TUBING KIT
K932806 · GCJ
Mayaguez Medical Center
General & Plastic Surgery · 63d
Cleared Aug 11, 1993
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2
K933317 · JJY
Bio-Rad
Chemistry · 35d
Cleared Aug 10, 1993
ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP
K922136 · CGA
Home Diagnostics, Inc.
Chemistry · 475d
Cleared Aug 10, 1993
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
K922137 · CGA
Home Diagnostics, Inc.
Chemistry · 475d
Cleared Aug 10, 1993
SURESEAL BANDAGE
K922441 · KGX
Gainor Medical Europe, Ltd.
General & Plastic Surgery · 445d
Cleared Aug 10, 1993
UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG
K924689 · LYR
United Biotech, Inc.
Microbiology · 327d
Cleared Aug 10, 1993
NASAL DORSUM
K925743 · FZE
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 270d
Cleared Aug 10, 1993
UNITIPS SURGICAL INSTRUMENTS
K925882 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 264d
Cleared Aug 10, 1993
UNICHANNEL(TM SURGICAL GRASPER
K925917 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 260d
Cleared Aug 10, 1993
STAPH-A-LEX(TM) SYSTEM
K926173 · JWX
Trinity Laboratories, Inc.
Microbiology · 245d
Cleared Aug 10, 1993
BARD MINI-INFUSER 1500 & 3000
K930459 · FRN
Bard Medsystems Div.
General Hospital · 194d
Cleared Aug 10, 1993
UNITIPS
K930809 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 175d