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
78913–78936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2001
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES...
K011224 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 14d
Cleared May 03, 2001
TISSUE MARKER
K001807 · GDW
Advanced Uroscience, Inc.
General & Plastic Surgery · 322d
Cleared May 03, 2001
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
K002256 · DSP
Arrow Intl., Inc.
Cardiovascular · 282d
Cleared May 03, 2001
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230...
K002565 · GXD
Baylis Medical Co., Inc.
Neurology · 259d
Cleared May 03, 2001
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
K003458 · HGP
Clinical Innovations, Inc.
Obstetrics & Gynecology · 177d
Cleared May 03, 2001
SANARUS CORE TISSUE BIOPSY SYSTEM
K003528 · KNW
Endocare, Inc.
Gastroenterology & Urology · 168d
Cleared May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344 · KTT
Synthes (Usa)
Orthopedic · 87d
Cleared May 03, 2001
TANTALUM BEADS - RADIOGRAPHIC MARKER
K010348 · NEU
Biomet, Inc.
General & Plastic Surgery · 87d
Cleared May 03, 2001
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE)...
K010483 · LYY
Pt. Medisafe Technologies
General Hospital · 72d
Cleared May 03, 2001
BIPOLAR PENCIL, MODEL 3901-002, 3900-002
K010487 · GEI
Medtronic PS Medical
General & Plastic Surgery · 72d
Cleared May 03, 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499 · JEY
Synthes (Usa)
Dental · 71d
Cleared May 03, 2001
NEUROPLUS, MODEL A10040, A10041, A10042, A10043
K010638 · GXY
Vermont Medical, Inc.
Neurology · 59d
Cleared May 03, 2001
MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
K010661 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 63d
Cleared May 03, 2001
KOALA CLAMP
K010695 · HFW
Maternus, Inc.
Obstetrics & Gynecology · 56d
Cleared May 03, 2001
LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF...
K010863 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 42d
Cleared May 03, 2001
KILEJIAN CIRCUMCISOR
K010867 · HFX
Iris Surgical, LLC
Obstetrics & Gynecology · 42d
Cleared May 03, 2001
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
K010991 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 30d
Cleared May 03, 2001
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 17d
Cleared May 02, 2001
VASCULAR ASSIST
K002186 · DPW
Huntleigh Healthcare, Inc.
Cardiovascular · 286d
Cleared May 02, 2001
MACROPORENS CRANILOC
K002334 · GXR
Macropore Biosurgery, Inc.
Neurology · 274d
Cleared May 02, 2001
SYNETEC
K002817 · DQK
Ela Medical, Inc.
Cardiovascular · 233d
Cleared May 02, 2001
PTA-OS SIZING BALLOON, MODEL 360
K003320 · MJN
NuMED, Inc.
Cardiovascular · 190d
Cleared May 02, 2001
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
K003819 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 142d
Cleared May 02, 2001
GLOBAL BY BLASTOCYST MEDIA
K010183 · MQL
Intl., Inc.
Obstetrics & Gynecology · 103d