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
117025–117048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1992
AMSEN DOUBLE-ENDED FORAMINAL PROBE
K921642 · LXH
Advanced Med/Surg, Inc.
Orthopedic · 58d
Cleared Jun 03, 1992
AMSEN POSTERIOR DISC EVACUATOR
K921643 · LXH
Advanced Med/Surg, Inc.
Orthopedic · 58d
Cleared Jun 03, 1992
AMSEN HOCKEY STICK CHISEL
K921644 · LXH
Advanced Med/Surg, Inc.
Orthopedic · 58d
Cleared Jun 03, 1992
AMSEN SPINE IMPACTOR INSTRUMENTS
K921645 · LXH
Advanced Med/Surg, Inc.
Orthopedic · 58d
Cleared Jun 03, 1992
INTERJET(TM) GINGIVAL CARE INSTRUMENT
K921999 · EFS
Bausch & Lomb, Inc.
Dental · 35d
Cleared Jun 03, 1992
IPT CAPSULE MIXER
K922203 · EFD
Ipt Technologies, Inc.
Dental · 23d
Cleared Jun 02, 1992
CRIT-SCAN
K910077 · DQA
Noninvasive Medical Technology Corp.
Anesthesiology · 510d
Cleared Jun 02, 1992
PHOENIX 5 URODYNAMICS SYSTEM
K914300 · FAP
Aspen Medical , Ltd.
Gastroenterology & Urology · 251d
Cleared Jun 02, 1992
MICROAIRE(R) FACIAL BONE PLATING SYSTEM
K914998 · HRS
Micro Surgical Instruments Corp.
Orthopedic · 208d
Cleared Jun 02, 1992
BIO-POLAR FORCEPS
K915826 · GEI
Applied Medical
General & Plastic Surgery · 155d
Cleared Jun 02, 1992
BIO-DETEK TRACERITE EEG ELECTRODE
K920264 · GXY
Bio-Detek, Inc.
Neurology · 133d
Cleared Jun 02, 1992
SILCLAMPS DEGANIA SILICONE
K920501 · DXC
Puritas Health Care, Inc.
Cardiovascular · 119d
Cleared Jun 02, 1992
ENDOTRACHEAL TUBE STYLET
K921128 · BSR
Eastmed Enterprises, Inc.
Anesthesiology · 84d
Cleared Jun 02, 1992
ORS-2000 SERIES
K921633 · LHC
Mnlase, Inc.
General Hospital · 57d
Cleared Jun 01, 1992
JIFFI CONDOM (RUBBER) CONTRACEPTIVE
K913813 · HIS
Sime Health, Ltd.
Obstetrics & Gynecology · 280d
Cleared May 31, 1992
BARRIER DRAPE SHEET WITH SYMETRY FABRIC
K920995 · KKX
Johnson & Johnson Medical, Inc.
General Hospital · 90d
Cleared May 31, 1992
BARRIER SURGICAL GOWN WITH SYMETRY FABRIC
K920996 · FYA
Johnson & Johnson Medical, Inc.
General Hospital · 90d
Cleared May 31, 1992
CD-CHEX
K920997 · GGL
Streck Laboratories, Inc.
Hematology · 90d
Cleared May 29, 1992
PRESTITCH
K910449 · KCY
Crantec Co.
General & Plastic Surgery · 486d
Cleared May 29, 1992
AUGUSTINE FIBEROPTIC LARYNGOSCOPE
K915161 · CCW
Augustine Medical, Inc.
Anesthesiology · 197d
Cleared May 29, 1992
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
K915526 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 171d
Cleared May 29, 1992
PROCEL BURN COVER
K915695 · MGP
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 158d
Cleared May 29, 1992
MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES
K915821 · NAB
Kerma Medical Products, Inc.
General & Plastic Surgery · 151d
Cleared May 29, 1992
PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
K920282 · NAB
Trinity Laboratories, Inc.
General & Plastic Surgery · 128d