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
147721–147744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1985
HEARING AID(ALL IN THE EAR)
K851427 · ESD
Woodard Hearing Aid Center
Ear, Nose, Throat · 82d
Cleared Jul 01, 1985
ACCURATECARE I & ACCURATECARE II
K851511 · GZJ
Sunnex, Inc.
Neurology · 77d
Cleared Jul 01, 1985
SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE
K851659 · HAW
Medco Products, Co., Inc.
Neurology · 69d
Cleared Jul 01, 1985
500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA
K851708 · EMG
Artiberia
Dental · 67d
Cleared Jul 01, 1985
2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS
K851728 · GEN
Artiberia
General & Plastic Surgery · 67d
Cleared Jul 01, 1985
VACUUM COMPRESSION INJECTOR
K851809 · KZE
Uci Corp.
General Hospital · 66d
Cleared Jul 01, 1985
DAHLBERT MODEL DE BEHING-THE-EAR HEARING AID
K851868 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 63d
Cleared Jul 01, 1985
MAX-I-PROBE HANDPIECE
K851944 · EIC
Solo Pak Laboratories
Dental · 59d
Cleared Jul 01, 1985
PHOTO CURING LIGHT
K852151 · EBF
Dentsply Intl.
Dental · 45d
Cleared Jul 01, 1985
SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.
K852180
Surgidyne, Inc.
General & Plastic Surgery · 42d
Cleared Jul 01, 1985
SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201
K852279 · JEQ
Northern Electric Co. Div. of Sunbeam...
Dental · 33d
Cleared Jul 01, 1985
INOX THERMOMETER JAR
K852301 · FLK
Broadwest Corp.
General Hospital · 33d
Cleared Jul 01, 1985
PNEUMOSCOPE
K852337 · BZG
Erich Jaeger, Inc.
Anesthesiology · 31d
Cleared Jul 01, 1985
DISTALITE POSTERIA DENTAL RESTORATIVE
K852344 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 28d
Cleared Jul 01, 1985
PLAK SMACKER
K852400 · EFW
Plak Smacker Toothbrush Co.
Dental · 25d
Cleared Jul 01, 1985
UNION BROACH BLEACHING LIGHT
K852474
Union Broach, Div. Moyco Industries,...
Dental · 20d
Cleared Jul 01, 1985
PROPOL DENTAL POLISHING PASTE
K852489 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 24d
Cleared Jul 01, 1985
OHMEDA CPU MONITOR
K852504
Ohmeda Medical
Cardiovascular · 19d
Cleared Jul 01, 1985
ULTRASONIC TOOTH SCALER MODEL DSCIOP
K852540 · ELC
Parkell, Inc.
Dental · 17d
Cleared Jun 28, 1985
CARDIAC EVENT RECORDER
K843533 · DRT
Cryo2 Corp.
Cardiovascular · 294d
Cleared Jun 28, 1985
GORE-TEX TISSUE MATRIX
K844142
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 248d
Cleared Jun 28, 1985
HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL
K844779 · BXB
Roadmaster Corp.
Physical Medicine · 200d
Cleared Jun 28, 1985
EMIT ANCILLARY REAGENTS
K844947 · KIE
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT AMITRIPTYLINE ASSAY
K844950 · LFG
Syva Co.
Toxicology · 190d