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
81721–81744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2000
OPAQUE HERRICK PLUG, 0.3MM
K001737 · LZU
Lacrimedics, Inc.
Ophthalmic · 12d
Cleared Jun 19, 2000
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
K994239 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 186d
Cleared Jun 16, 2000
TEARAWAY INTRODUCER SHEATH
K000313 · DYB
Xentek Medical, Inc.
Cardiovascular · 136d
Cleared Jun 16, 2000
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
K000433 · LKF
Medical Device Technologies, Inc.
Obstetrics & Gynecology · 128d
Cleared Jun 16, 2000
CONTEMPRO-MIST
K000543 · CAF
Contemporary Products, Inc.
Anesthesiology · 119d
Cleared Jun 16, 2000
ABSOLUTE HCG PREGNANCY TEST
K000844 · DHA
Mizuho USA, Inc.
Chemistry · 93d
Cleared Jun 16, 2000
CHAD THERAPEUTICS OXYMATIC MODEL 401
K000890 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 88d
Cleared Jun 16, 2000
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND...
K000892 · OLT
Datex-Ohmeda, Inc.
Neurology · 88d
Cleared Jun 16, 2000
ULTRASTIM ELECTRODE, MODEL US4040
K000947 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 85d
Cleared Jun 16, 2000
PLACER MODEL 6232 STEERABLE STYLET
K000955 · DRB
Medtronic Vascular
Cardiovascular · 84d
Cleared Jun 16, 2000
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
K000972 · LXT
Synthes (Usa)
Orthopedic · 81d
Cleared Jun 16, 2000
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
K000996 · EFT
Dentsply Intl.
Dental · 80d
Cleared Jun 16, 2000
SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
K001463 · EBI
Davis Schottlander & Davis, Ltd.
Dental · 37d
Cleared Jun 16, 2000
DYNA-LOK CLASSIC SPINAL SYSTEM
K001532 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Jun 16, 2000
ECHOCOM, IMAGECOM, DOKUCOM
K001592 · DQK
Tomtec Imaging Systems GmbH
Cardiovascular · 24d
Cleared Jun 15, 2000
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
K001039 · LPH
Implex Corp.
Orthopedic · 76d
Cleared Jun 15, 2000
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
K001082 · FYD
Stackhouse, Inc.
General Hospital · 72d
Cleared Jun 15, 2000
TRANS FX ADJUSTABLE PIN TO BAR CLAMP
K001084 · LXT
Immedica, Inc.
Orthopedic · 72d
Cleared Jun 15, 2000
PIPET CURET
K001545 · HHK
Milex Products, Inc.
Obstetrics & Gynecology · 28d
Cleared Jun 15, 2000
MACH 7
K990060 · KOJ
Kreativ, Inc.
Dental · 524d
Cleared Jun 15, 2000
STERRAD 100S STERILIZER
K991999 · MLR
Advanced Sterilization Products
General Hospital · 367d
Cleared Jun 14, 2000
AC POWERED THERMAL CAUTERY UNIT
K000893 · HQO
Starion Instruments
Ophthalmic · 86d
Cleared Jun 14, 2000
NBS CONNECTING TUBE SET
K001068 · HIF
Nbs Products CO
Obstetrics & Gynecology · 72d
Cleared Jun 14, 2000
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
K001112 · DXJ
General Electric Medical Systems...
Cardiovascular · 69d