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
120721–120744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1991
MONOSCOPY BRAND 5MM LOCK TROCAR SLEEVE, MODIFIED
K912980 · GCJ
Dexide, Inc.
General & Plastic Surgery · 32d
Cleared Jul 26, 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jul 25, 1991
GATES GLIDDEN DRILLS
K905418 · DZA
The Hygenic Corp.
Dental · 233d
Cleared Jul 25, 1991
DIMAC WIRES
K910090 · DYX
Instrumentations Unltd.
Dental · 197d
Cleared Jul 25, 1991
WYMAN SUTURE WASHER
K910186 · HTN
Acu Med, Inc.
Orthopedic · 191d
Cleared Jul 25, 1991
PRECISE BARND PI DISPOSABLE SURGICAL STAPLES
K911252 · GDW
3M Medical Products Group
General & Plastic Surgery · 126d
Cleared Jul 25, 1991
BRANEMARK SYSTEM-5.0MM FIXTURE
K911961 · DZE
Nobelpharma USA, Inc.
Dental · 84d
Cleared Jul 25, 1991
SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS
K912004 · IRP
Shepherd Medical Products, Inc.
Physical Medicine · 80d
Cleared Jul 25, 1991
DISPOSABLE O.R. TOWEL
K912110 · KKX
American Threshold Industries, Inc.
General Hospital · 73d
Cleared Jul 25, 1991
TBD, LENS MEASURING DEVICE
K912134 · HRJ
Alcon Laboratories
Ophthalmic · 72d
Cleared Jul 25, 1991
LANDERS THREE STRUT VITRECTOMY LENS RING
K912151 · HNH
Ocular Instruments, Inc.
Ophthalmic · 71d
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