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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125689–125712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1990
TRANS/R - FP(3)
K900016 · FCY
CIVCO Medical Instruments Co., Inc.
Gastroenterology & Urology · 160d
Cleared Jun 11, 1990
DYNATRON 330 BODY COMPOSITION ANALYZER
K900321 · DSB
Dynatronics Laser Corp.
Cardiovascular · 139d
Cleared Jun 11, 1990
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM
K900494 · FAP
Synectics-Dantec
Gastroenterology & Urology · 129d
Cleared Jun 11, 1990
CAAS UNICOMPARMENTAL KNEE SYSTEM
K900619 · HSX
Techmedica, Inc.
Orthopedic · 123d
Cleared Jun 11, 1990
INSITE STEERABLE GUIDEWIRE
K901224 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 89d
Cleared Jun 11, 1990
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
K901249 · DTZ
Shiley, Inc.
Cardiovascular · 87d
Cleared Jun 11, 1990
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
K901250 · DTZ
Shiley, Inc.
Cardiovascular · 87d
Cleared Jun 11, 1990
BIOPSY FORCEPS (NON-RIGID)
K901339 · KNW
Applied Medical Technologies
Gastroenterology & Urology · 81d
Cleared Jun 11, 1990
DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN
K901439 · FEB
Telemed Systems, Inc.
General Hospital · 77d
Cleared Jun 11, 1990
CORPAK GASTROSTOMY TUBE
K901501 · KGC
Corpak Co.
Gastroenterology & Urology · 73d
Cleared Jun 11, 1990
ESCORT MODEL 300
K902060 · DQA
Medical Data Electronics
Anesthesiology · 35d
Cleared Jun 11, 1990
RX ROCKER TRIUMPH, JR. WHEELCHAIR
K902440 · IOR
The RX Rocker Corp.
Physical Medicine · 10d
Cleared Jun 11, 1990
CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER
K902452 · BXB
Berner Assoc., Inc.
Physical Medicine · 10d
Cleared Jun 11, 1990
TITAN HERCULES ADJUSTING TABLE
K902465 · INW
Titan Tables
Physical Medicine · 7d
Cleared Jun 11, 1990
TITAN ZODIAC ADJUSTING TABLE
K902466 · INW
Titan Tables
Physical Medicine · 7d
Cleared Jun 08, 1990
AMBU LIFE KEY AND AMBU RES-CUE KEY
K900260 · BTM
Ambu, Inc.
Anesthesiology · 142d
Cleared Jun 08, 1990
NEOSERV 824
K900729 · MCJ
Burdick Corp.
Orthopedic · 113d
Cleared Jun 08, 1990
HOME URODATA SYSTEM(TM)
K900770 · EXY
Biodan Medical Systems, Ltd.
Gastroenterology & Urology · 112d
Cleared Jun 08, 1990
NON-PRESCRIPTION SUNGLASSES
K901036 · HQY
The Bonneau Co.
Ophthalmic · 94d
Cleared Jun 08, 1990
VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR
K901046 · FPA
Vlv Associates, Inc.
General Hospital · 94d
Cleared Jun 08, 1990
PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY
K901081 · FPA
Vlv Associates, Inc.
General Hospital · 93d
Cleared Jun 08, 1990
DURACATH
K901133 · LFJ
Impra, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 08, 1990
RMI CARDIOPLEGIA DELIVERY KITS
K901231 · DWF
Research Medical, Inc.
Cardiovascular · 86d
Cleared Jun 08, 1990
CORE DISPOSABLE TROCARS
K901407 · HET
Core Dynamics, Inc.
Obstetrics & Gynecology · 74d