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
120457–120480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1991
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
K912318 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 62d
Cleared Jul 25, 1991
COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC
K912485 · ELW
Coltene/Whaledent, Inc.
Dental · 51d
Cleared Jul 25, 1991
LAPAROSCOPIC LASER FIBER DIVERTER
K912502 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 50d
Cleared Jul 25, 1991
OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER
K912522 · EQH
Summit Technology, Inc.
Ear, Nose, Throat · 64d
Cleared Jul 25, 1991
NARKOMED AV-E VENTILATOR
K912533 · CBK
Draeger Medical, Inc.
Anesthesiology · 48d
Cleared Jul 25, 1991
BLOOD PRESSURE CUFFS
K912638 · DXQ
Vital Signs, Inc.
Cardiovascular · 41d
Cleared Jul 25, 1991
RT40 RADIO TRANSLUCENT
K912714 · DRX
Bio-Detek, Inc.
Cardiovascular · 37d
Cleared Jul 25, 1991
KALLESTEAD TOTAL IGE MICROPLATE KIT
K912800 · DGC
Bio-Rad Laboratories, Inc.
Immunology · 30d
Cleared Jul 24, 1991
E560 ELECTROCARDIOGRAPH
K903565 · LOS
Burdick Corp.
Cardiovascular · 351d
Cleared Jul 24, 1991
ELITE II ELECTROCARDIOGRAPH
K904032 · LOS
Burdick Corp.
Cardiovascular · 327d
Cleared Jul 24, 1991
CROMATEST SYPHILIS DIAGNOSTIC
K904496 · GMQ
Biotrax, Inc.
Microbiology · 295d
Cleared Jul 24, 1991
OPTYX
K904883 · JXG
Baxter Healthcare Corp
Neurology · 271d
Cleared Jul 24, 1991
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
K904899 · BTM
Vital Signs, Inc.
Anesthesiology · 267d
Cleared Jul 24, 1991
SOFT TISSUE SUTURE WASHER/3 HOLE WASHER
K910229 · HTN
Depuy, Inc.
Orthopedic · 187d
Cleared Jul 24, 1991
BARD REPLACEMENT GASTROSTOMY TUBE
K910492 · KGC
C.R. Bard, Inc.
Gastroenterology & Urology · 169d
Cleared Jul 24, 1991
DC200 DEFIBRILLATOR
K910634 · LDD
Siemens Burdick, Inc.
Cardiovascular · 161d
Cleared Jul 24, 1991
SPINAL TAP NEEDLE
K910652 · BSP
Gesco Intl., Inc.
Anesthesiology · 160d
Cleared Jul 24, 1991
SFA-II MICROPROCESSOR-CONTROLLED MODULE
K910905 · DRQ
Life Sciences Manufacturing, Inc.
Cardiovascular · 141d
Cleared Jul 24, 1991
ICON STREP B IMMUNOENZYMETRIC ASSAY
K911417 · GTZ
Hybritech, Inc.
Microbiology · 114d
Cleared Jul 24, 1991
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
K911640 · GMT
Olympus Corp.
Microbiology · 107d
Cleared Jul 24, 1991
SALTER LABS NEONATAL NASAL OXYGEN CANNULA
K911740 · CAT
Salter Labs
Anesthesiology · 98d
Cleared Jul 24, 1991
GASPARAITIS ESOPHAGRAM CATHETER SET
K911897 · KNT
E-Z-Em, Inc.
Gastroenterology & Urology · 86d
Cleared Jul 24, 1991
HEPARIN ADSORBENT
K912061 · JPA
Sigma Diagnostics, Inc.
Hematology · 76d
Cleared Jul 24, 1991
SALTER LABS DISPOSABLE NIPPLE AND NUT
K912174 · CAN
Salter Labs
Anesthesiology · 69d