FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82225–82248 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2000
OCD2001
K992935 · NFB
Contemporary Products, Inc.
Anesthesiology · 294d
Cleared Jun 20, 2000
SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM
K993125 · FMI
Safety Medical Supply Int,., Inc.
General Hospital · 274d
Cleared Jun 20, 2000
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
K993176 · KGI
Norland Medical Systems, Inc.
Radiology · 272d
Cleared Jun 20, 2000
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
K993625 · HIF
Genicon, LC
Obstetrics & Gynecology · 238d
Cleared Jun 19, 2000
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
K000754 · JNB
Quantase , Ltd.
Chemistry · 103d
Cleared Jun 19, 2000
PC COATED FLUOROPLASTIC VENT TUBES
K000801 · ETD
Gyrus Ent LLC
Ear, Nose, Throat · 98d
Cleared Jun 19, 2000
CALIBRATION SOLUTION 1, MODEL A943-837
K001484 · JIX
Alko Diagnostic Corp.
Chemistry · 39d
Cleared Jun 19, 2000
ADVANTAGE THC TEST
K001567 · LDJ
Advantage Diagnostics Corp.
Toxicology · 31d
Cleared Jun 19, 2000
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
K001632 · JJY
Avl Scientific Corp.
Chemistry · 24d
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