FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133561–133584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1988
IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
K884278 · DTB
Telectronics, Inc.
Cardiovascular · 64d
Cleared Dec 15, 1988
MODIFIED JELTRODE(TM) ELECTRODES DEEMED
K884348 · GXY
Henley Intl.
Neurology · 62d
Cleared Dec 15, 1988
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
K884424 · JJW
Bio-Rad
Chemistry · 56d
Cleared Dec 15, 1988
UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS
K884693 · JIX
Biomedical Research & Development...
Chemistry · 36d
Cleared Dec 15, 1988
JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE
K884749 · KYZ
Johnson & Johnson Patient Care, Inc.
General Hospital · 31d
Cleared Dec 15, 1988
ALLEN PRONE ARMBOARD
K884838 · BTX
Edgewater Medical Systems, Inc.
General & Plastic Surgery · 24d
Cleared Dec 15, 1988
S 4 INSTRUMENT STAND
K884876 · FSH
Carl Zeiss, Inc.
General & Plastic Surgery · 24d
Cleared Dec 15, 1988
FREE ARM(TM)
K884928 · FWZ
Faro Medical Technologies, Inc.
General & Plastic Surgery · 17d
Cleared Dec 15, 1988
OCCUSHIELDS
K884929 · FXX
Dioptics
General Hospital · 17d
Cleared Dec 15, 1988
SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP
K884994 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 14d
Cleared Dec 14, 1988
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION
K882679 · HQB
Surgical Laser Technologies, Inc.
Ophthalmic · 169d
Cleared Dec 14, 1988
TAB PAK
K882731 · NXB
Dynex Trading Co.
General Hospital · 166d
Cleared Dec 14, 1988
WWDS-005 HUMAN RECTAL PROBE
K883079 · IYO
Ausonics Pty , Ltd.
Radiology · 146d
Cleared Dec 14, 1988
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
K883389 · JIW
Reagents Applications, Inc.
Chemistry · 126d
Cleared Dec 14, 1988
DELFIA THYROXINE (T4) KIT
K883559 · CDX
Pharmacia, Inc.
Chemistry · 117d
Cleared Dec 14, 1988
PUMPETTE(TM)
K884111 · JKA
Helena Laboratories
Chemistry · 76d
Cleared Dec 14, 1988
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
K884197 · JIT
Casco Standards
Chemistry · 69d
Cleared Dec 14, 1988
FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884201 · CEE
Cyberfluor, Inc.
Chemistry · 69d
Cleared Dec 14, 1988
VERSABLOT
K884258 · KPA
American Bionetics, Inc.
Chemistry · 64d
Cleared Dec 14, 1988
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
K884377 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Dec 14, 1988
TOTAL IRON BINDING CAPACITY TEST
K884649 · JQE
Sclavo, Inc.
Chemistry · 37d
Cleared Dec 13, 1988
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS
K881841 · DSB
Buckman Co., Inc.
Cardiovascular · 225d
Cleared Dec 13, 1988
HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT
K882657 · DYB
Harbor Medical Devices, Inc.
Cardiovascular · 167d
Cleared Dec 13, 1988
LYME DISEASE IFA (IGG)
K883487 · LSR
Hillcrest Biologicals
Microbiology · 119d