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
101665–101688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1995
HURRICANE
K952258 · HQY
Hurricane Hardware, Inc.
Ophthalmic · 77d
Cleared Jul 31, 1995
TI. ALLOY 2.0 MM CORTEX SCREW
K952272 · HWC
Synthes (Usa)
Orthopedic · 77d
Cleared Jul 31, 1995
ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)
K952325 · CCK
Icor AB
Anesthesiology · 74d
Cleared Jul 31, 1995
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, &...
K952555 · MOJ
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Jul 31, 1995
REDI DRILL DRILL SYSTEM
K952609 · EQJ
Trebay Medical Corp.
Ear, Nose, Throat · 54d
Cleared Jul 31, 1995
MEDLITE LASER SYSTEM
K952636 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 53d
Cleared Jul 31, 1995
CANNULATED PLUS HIP SCREW
K952640 · JDW
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared Jul 31, 1995
WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
K952691 · FJC
Welch Allyn, Inc.
Gastroenterology & Urology · 49d
Cleared Jul 31, 1995
SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS
K952733 · GEX
Myriad Lase, Inc.
General & Plastic Surgery · 46d
Cleared Jul 31, 1995
SACS, INDEPENDENT FIBER COOLANT SYSTEM
K952754 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 46d
Cleared Jul 31, 1995
ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION...
K952757 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 45d
Cleared Jul 31, 1995
ENDOPATH* TRISTAR FLAT BLADED SURGICAL OBTURATOR & SLEEVE
K952842 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 40d
Cleared Jul 31, 1995
ANGIOCATH & INSYTE AUTOGUARD CATHETERS
K952861 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 39d
Cleared Jul 31, 1995
QUESTUS DISPOSABLE ENDOSCOPIC KNIFE
K952926 · GCJ
Wrightmedicaltechnologyinc
General & Plastic Surgery · 35d
Cleared Jul 31, 1995
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
K953197 · DCK
Johnson & Johnson Clinical...
Immunology · 21d
Cleared Jul 31, 1995
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K953212 · DCK
Randox Laboratories, Ltd.
Immunology · 21d
Cleared Jul 31, 1995
COMPETITOR
K953426 · IOR
Kuschall of America
Physical Medicine · 10d
Cleared Jul 31, 1995
CHAMPION, 3000 REBEL
K953427 · IOR
Kuschall of America
Physical Medicine · 10d
Cleared Jul 31, 1995
CHAMPION, 3000
K953428 · IOR
Kuschall of America
Physical Medicine · 10d
Cleared Jul 31, 1995
CHAMPION, 1000
K953429 · IOR
Kuschall of America
Physical Medicine · 11d
Cleared Jul 28, 1995
NOVY CORNUAL CANNULATION SET
K931476 · MOV
Cook Ob/Gyn
Obstetrics & Gynecology · 856d
Cleared Jul 28, 1995
OVAMED INTRAUTERINE ACCESS CATHETER
K931534 · MOV
Ovamed Corp.
Obstetrics & Gynecology · 851d
Cleared Jul 28, 1995
EL-RF/3 (IGM-IGG-IGA) KIT
K941398 · DHR
Theratest Laboratories, Inc.
Immunology · 493d
Cleared Jul 28, 1995
CODMAN-MEDOS VALVE SHUNT SYSTEM
K944222 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 332d