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
82585–82608 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER...
K001198 · DQX
Datascope Corp.
Cardiovascular · 29d
Cleared May 12, 2000
ESPIRT
K001208 · CBK
Respironics, Inc.
Anesthesiology · 28d
Cleared May 12, 2000
GE SYSTEM FIVE
K001267 · IYN
Ge Medical Systems, Inc.
Radiology · 22d
Cleared May 12, 2000
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
K001368 · LHI
Carmel Pharma Ab.
General Hospital · 11d
Cleared May 12, 2000
BALLOON FOR ULTRASONIC ENDOSCOPES
K992178 · ITX
N.M. Beale Co., Inc.
Radiology · 319d
Cleared May 12, 2000
AIRPILOTMASK, MODEL TMS-900
K992192 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 318d
Cleared May 12, 2000
SPIROVIT SP-2, PNEUMOCHECK II
K992823 · BZG
Schiller AG
Anesthesiology · 263d
Cleared May 11, 2000
PQ1
K000189 · KLE
Ultradent Products, Inc.
Dental · 111d
Cleared May 11, 2000
LATERAL PIVOT INSERT
K000590 · JWH
Encore Orthopedics, Inc.
Orthopedic · 80d
Cleared May 11, 2000
STRYKER TRAUMA PLATING SYSTEM
K000636 · HRS
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared May 11, 2000
ERS RADIAL HEAD REPLACEMENT
K000658 · KWI
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared May 11, 2000
PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
K000694 · JDQ
Pectofix, Inc.
Orthopedic · 71d
Cleared May 11, 2000
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
K000706 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 70d
Cleared May 11, 2000
MD 10, SEM, SM 12, CBM
K000710 · EFB
NOUVAG AG
Dental · 70d
Cleared May 11, 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965 · MNI
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared May 11, 2000
RESPIRATORY BELT SENSOR, MODEL 6000S
K001030 · BZQ
Dymedix, Inc.
Anesthesiology · 42d
Cleared May 11, 2000
MODEL 4300 PSARRAY EEG ELECTRODE SET
K001055 · GXY
Physiometrix, Inc.
Neurology · 38d
Cleared May 11, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K001145 · GKP
Dade Behring, Inc.
Hematology · 31d
Cleared May 11, 2000
JEL BIOS 90 (CODE NAME RD-2401)
K001196 · EJT
J.F. Jelenko & Co., Inc.
Dental · 29d
Cleared May 11, 2000
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
K001197 · DIO
OraSure Technologies, Inc.
Toxicology · 30d
Cleared May 11, 2000
XIA SPINE SYSTEM
K001272 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared May 11, 2000
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE...
K991886 · KRB
Pulsion Medical Systems, Inc.
Cardiovascular · 344d
Cleared May 11, 2000
WAND PLUS
K992819 · EJI
Spintech, Inc.
Dental · 265d
Cleared May 11, 2000
UNI-LASER 430
K993815 · GEX
Medart Corp.
General & Plastic Surgery · 183d