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
136537–136560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1988
STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
K881254 · JQC
Norfolk Scientific, Inc.
Chemistry · 13d
Cleared Apr 05, 1988
XYLENE
K881282 · KEM
Anatech, Ltd.
Pathology · 11d
Cleared Apr 05, 1988
ANIMAL AND HUMAN SERA
K881287 · KIS
Cell Culture Laboratories
Pathology · 8d
Cleared Apr 04, 1988
NOVO VIVO MODEL #17140 AND #17135
K880377 · GAA
Genesis Industries, Inc.
General & Plastic Surgery · 68d
Cleared Apr 04, 1988
BOVINE CALF SERUM SUPPLEMENTED #A-2159
K880471 · KIS
Hyclone Laboratories, Inc.
Pathology · 61d
Cleared Apr 04, 1988
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER
K880507 · GKZ
Coulter Electronics, Inc.
Hematology · 55d
Cleared Apr 04, 1988
MCT 8000 (MULTI-VISION CONTRAST TESTER)
K881059 · HOX
Vistech Consultants, Inc.
Ophthalmic · 24d
Cleared Apr 04, 1988
RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201
K881243 · LFX
Labsystems, Inc.
Microbiology · 14d
Cleared Apr 01, 1988
TEGASORB ULCER DRESSING #90-XXX
K872298 · FRO
3M Company
General & Plastic Surgery · 291d
Cleared Apr 01, 1988
BREATHGUARD APNEA MONITOR
K872833 · BZQ
Lada Intl., Inc.
Anesthesiology · 259d
Cleared Apr 01, 1988
FRAME, SPECTACLE
K873965 · HQZ
Swank Plus , Ltd.
Ophthalmic · 185d
Cleared Apr 01, 1988
GUIDE WIRE INTRODUCER
K873972 · DQX
Target Therapeutics
Cardiovascular · 185d
Cleared Apr 01, 1988
CIRCADIAN STRESS TEST II
K874641 · DPS
Circadian, Inc.
Cardiovascular · 140d
Cleared Apr 01, 1988
SITE SOLUTION ADMINISTRATION SET
K874725 · FPA
Site Microsurgical Systems, Inc.
General Hospital · 135d
Cleared Apr 01, 1988
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000
K874816 · DSP
Kontron Instruments, Inc.
Cardiovascular · 120d
Cleared Apr 01, 1988
COBE CML3
K880021 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 87d
Cleared Apr 01, 1988
EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
K880052 · DTJ
Baxter Healthcare Corp
Cardiovascular · 86d
Cleared Apr 01, 1988
BOVINE CALF SERUM CATALOG #A-2119
K880470 · KIS
Hyclone Laboratories, Inc.
Pathology · 58d
Cleared Apr 01, 1988
MULTISURFACE ROLLER BOTTLE (M.S.R.B.)
K880509 · KJC
Motil Plastics , Ltd.
Pathology · 51d
Cleared Apr 01, 1988
WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY
K880544 · GJL
Wescor, Inc.
Hematology · 52d
Cleared Apr 01, 1988
DIACYTE FIXATIVE SOLUTION
K880549 · LDY
Cytocorp, Inc.
Pathology · 52d
Cleared Apr 01, 1988
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
K880647 · HOX
Fred Sammons, Inc.
Ophthalmic · 45d
Cleared Apr 01, 1988
EASY SHIELD ADHESIVE BANDAGE
K880675 · HOY
Eye Garter Company, Inc.
Ophthalmic · 42d
Cleared Apr 01, 1988
CALIFORNIA CONVERTIBLES (SUNGLASSES)
K880709 · HQY
Jmj World Trade Corp.
Ophthalmic · 39d