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
117289–117312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1992
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
K920378 · LSK
Gen-Probe, Inc.
Microbiology · 91d
Cleared Apr 29, 1992
ROCHE COBAS MIRA PLUS
K920402 · JJE
Roche Diagnostic Systems, Inc.
Chemistry · 89d
Cleared Apr 29, 1992
B-D INTERLINK SYRINGE CANNULA
K920422 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 89d
Cleared Apr 29, 1992
10% PHOSPHORIC ACID ETCHING GEL
K920483 · EBF
Pulpdent Corp.
Dental · 90d
Cleared Apr 29, 1992
PUPLDENT ETCH N PREP
K920485 · EBF
Pulpdent Corp.
Dental · 90d
Cleared Apr 29, 1992
SYSMEX HEMATOLOGY SYSTEM ACCESSORIES
K920544 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 83d
Cleared Apr 29, 1992
ANGLED DELIVERY DEVICE
K920589 · GEX
Laserscope
General & Plastic Surgery · 79d
Cleared Apr 29, 1992
MICRO-COLL COLLAGEN DERMAL WOUND SPRAY
K920642 · MGQ
Micro-Collagen Pharmaceutics, Ltd.
General & Plastic Surgery · 77d
Cleared Apr 29, 1992
CRITSPIN MICRO-HEMATOCRIT
K920759 · GKG
Stat-Spin Technologies
Hematology · 70d
Cleared Apr 29, 1992
HALOCATH LASER CATHETERS
K920934 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 61d
Cleared Apr 29, 1992
AUTOLOADER
K921005 · JQW
Innovative Medical Systems, Inc.
Hematology · 57d
Cleared Apr 29, 1992
FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER
K921069 · INI
Fortress Scientific , Ltd.
Physical Medicine · 62d
Cleared Apr 29, 1992
LYPHOCHEK(R) FRUCTOSAMINE CONTROL
K921089 · JJX
Bio-Rad
Chemistry · 54d
Cleared Apr 29, 1992
PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT
K921095 · GBX
Pacer Tool & Plastics, Inc.
General & Plastic Surgery · 54d
Cleared Apr 29, 1992
HCG CONTROL
K921206 · JJX
Polymedco, Inc.
Chemistry · 47d
Cleared Apr 29, 1992
SURGICAL INSTRUMENT STAND
K921210 · MDM
Murphy Medical Center
General & Plastic Surgery · 48d
Cleared Apr 29, 1992
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
K921455 · CFE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Apr 29, 1992
DRAKE & DRAKE/200 DL
K921467 · INI
Am Scooters
Physical Medicine · 33d
Cleared Apr 29, 1992
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
K921636 · GIM
Bd Becton Dickinson Vacutainer...
Chemistry · 23d
Cleared Apr 29, 1992
HAZEL II
K921768 · IOQ
Kinetic Concepts, Inc.
Physical Medicine · 15d
Cleared Apr 29, 1992
VACUTAINER(R) BRAND SST(R) AND CAT TUBES
K921806 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 14d
Cleared Apr 29, 1992
RIFTON MOR219 19 & RIFTON MOR225 25
K921817 · INM
Rifton Equipment For the Handicapped
Physical Medicine · 14d
Cleared Apr 29, 1992
RIONET HEARING AID HB-52S
K921829 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 13d
Cleared Apr 28, 1992
K3 COMPUTER SYSTEMS
K902977 · DPT
Donald L. King M.D.
Radiology · 662d