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
121177–121200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1991
PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480
K912112 · LQJ
Tomey Corporation USA
Ophthalmic · 35d
Cleared Jun 17, 1991
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR
K912153 · ESD
Qualitone
Ear, Nose, Throat · 33d
Cleared Jun 17, 1991
QUALITONE MODEL 48 C-WR-BEHIND THE EAR
K912154 · ESD
Qualitone
Ear, Nose, Throat · 33d
Cleared Jun 17, 1991
MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK
K912321 · JGJ
Nova Biomedical Corp.
Chemistry · 24d
Cleared Jun 17, 1991
PDT CARRYALL TRANSMITTER, VARIOUS MODELS
K912379 · DXH
Cardiac Pacemakers, Inc.
Cardiovascular · 19d
Cleared Jun 14, 1991
CW DOPPLER/4.5 MHZ
K903984 · ITX
Diasonics, Inc.
Radiology · 289d
Cleared Jun 14, 1991
LIMA COLLARED CL STEM
K910836 · JDI
Lima Intl. Corp.
Orthopedic · 107d
Cleared Jun 14, 1991
B-D SAFETY-LOK(TM) I.V. NEEDLES
K911136 · FPA
Bd Becton Dickinson Vacutainer...
General Hospital · 92d
Cleared Jun 14, 1991
HAND CARRIED STRETCHER
K911765 · FPP
L.E. Phillips Career Development...
General Hospital · 56d
Cleared Jun 13, 1991
TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES
K905234 · CBK
Percussionaire Corp.
Anesthesiology · 218d
Cleared Jun 13, 1991
THACKRAY TITANIUM MINI-PLATING SYSTEM
K905774 · HRS
Depuy, Inc.
Orthopedic · 168d
Cleared Jun 13, 1991
PALL 3N1 FILTER
K905794 · FPB
Pall Biomedical Products Co.
General Hospital · 168d
Cleared Jun 13, 1991
BIOPRO METAL BACKED CEMENTED ACETABULAR CUP
K910352 · JDI
Biopro, Inc.
Orthopedic · 135d
Cleared Jun 13, 1991
RUBBER LATEX SURGEONS GLOVES
K910928 · KGO
Regent Hospital Products
General Hospital · 100d
Cleared Jun 13, 1991
SURGICAL RUBBER GLOVES
K911268 · KGO
Pacificlink Export
General Hospital · 83d
Cleared Jun 13, 1991
NUCLETRON PLANNING SYSTEM
K911612 · IYE
Nucletron-Oldelft Corp.
Radiology · 63d
Cleared Jun 13, 1991
STI TISSUE MANIPULATOR
K911699 · HIN
Surgical Technologies, Inc.
Obstetrics & Gynecology · 58d
Cleared Jun 13, 1991
ANEMIA I, II
K911984 · JJY
Ciba Corning Diagnostics Corp.
Hematology · 41d
Cleared Jun 12, 1991
PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA
K904573 · ODG
Pentax Precision Instrument Corp.
Radiology · 246d
Cleared Jun 12, 1991
NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION
K905810 · JWH
Joint Medical Products Corp.
Orthopedic · 168d
Cleared Jun 12, 1991
ELISA COMBI-KIT HUMAN IGG SUBCLASSES
K911610 · DEW
Janssen Research Foundation
Immunology · 79d
Cleared Jun 11, 1991
PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT
K905056 · DSP
Datascope Corp.
Cardiovascular · 215d
Cleared Jun 11, 1991
LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED
K905522 · IYO
Laboratory Equipment Corp.
Radiology · 183d
Cleared Jun 11, 1991
CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
K910696 · LFL
Valleylab, Inc.
General & Plastic Surgery · 112d